anesthesia. personalized. - medtronic · 2017-03-22 · anesthesia. personalized. bispectral...
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ANESTHESIA. PERSONALIZED.Bispectral Index™ (BIS™) monitoring system product guide
INSIGHTS FROM RELIABLE DATAReliable data based on objective, quantified science. We know how important it is.
BIS™ monitors use innovative technology to link patient-specific EEG information to individual clinical states.
Here’s how it works:
1. Sensors collect the raw EEG data that indicates brain activity in real time.
2. The system uses its clinically validated algorithm to filter, analyze, and correlate the data.
3. Results are continually calculated and displayed as the BIS™ index (a number between 0 and 100), indicating the patient’s response to anesthetic agents.
You may improve clinical outcomes by customizing individual dosing to keep the BIS™ monitor value within the target range during all phases of anesthesia.1,4-10
Personalize anesthetic dosing. For better patient comfort — and to reduce complications.1,2
BIS™ brain function monitoring:
∙ Can help you reduce anesthesia use by up to 50%3
∙ Streamlines patient emergence time and discharge from the PACU4
∙ Indicates hypnotic effect through the easy-to-read BIS™ index
∙ Facilitates improved patient outcomes.1,2,5
2-channel monitorThis monitor:
∙ Includes a user-configurable display
∙ Is a versatile platform designed for future expandability
Part number 186-02105 year warranty
BIS™ LoC 2 channel with patient interface cable (PIC+)Product ID: 186-0195-AMSPIC+ only: 186-0107
4-channel monitorThe same proven BIS™ anesthetic depth monitoring, with enhanced bihemispheric capabilities.
Combine it with our bilateral sensors to detect hemispheric differences in the brain. It features:
∙ Asymmetry indicator (ASYM)
∙ Ability to trend BIS™-Left and BIS™-Right values Density spectral array (DSA)
Part number 186-10145 year warranty
BIS™ LoC 4 channel with patient interface cable (PIC-4)Product ID: 186-0224-AMSPIC-4 only: 186-1018-AMS
© 2016 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. 02/2017-16-PM-0168(1)-[WF#1580984]
References
1. Luginbühl M, Wüthrich S, Petersen-Felix S, et al. Different benefit of bispectal index (BIS) in desflurane and propofol anesthesia. Acta Anaesthesiol Scand. 2003;47(2):165-173.
2. Liu SS. Effects of bispectral index monitoring on ambulatory anesthesia: a meta-analysis of randomized controlled trials and a cost analysis. Anesthesiology. 2004;101(2):311-315.
3. Chan MT, Cheng BC, Lee TM, et al. BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013;25:33–42.
4. Gan TJ, Glass PS, Windsor A, et al. Bispectral index monitoring allows faster emergence and improved recovery from propofol, alfentanil, and nitrous oxide anesthesia. BIS Utility Study Group. Anesthesiology. 1997;87(4):808-815.
5. Punjasawadwong Y, Phongchiewboon A, Bunchungmongkol N. Bispectral index for improving anaesthetic delivery and postoperative recovery (review). Cochrane Database Syst Rev. 2007;4:CD003843.
6135 Gunbarrel AvenueBoulder, CO 80301 800.635.5267 medtronic.com/covidien
IMPROVE PERFORMANCE High-quality sensors that are easy to apply, with positioning instructions printed right on them. They adhere well to skin and are comfortable for your patient. Limited for short term use (maximum of 24 hours).
BIS™ quatro 4-electrode sensorMeasures brain activity in adult patients undergoing general anesthesia or sedation.
Part number 186-0106, box of 25
BIS™
4 Electrode SensorTechnical Data Sheet
Parameter Description
Sensor dimensions: 11” x 1.1” (approx.)
Weight: 3.7 g (approx.)
Weight (packaged): 16.8 g (approx.)
Packaging: 25 individually packaged sensors per box
Shelf Life: One and a half years from date of manufacture
Sensor Element Material Description
Connector (Paddle): Polycarbonate plastic (Incidental patient contact)
Tab Stiffener: Polycarbonate sheet (No patient contact)One side coated with adhesive
Module: Copper/brass/Kapton (No patient contact)
Flexible Circuit: Polyester screen-printed with cured Ag/AgCl anddielectric inks (Incidental patient contact)
Electrode Gel: Potassium Chloride (KCl) aqueous gel
Electrode Tines Disk: Green nylon plastic
Electrode Sponge Disk: Polyurethane/polyester foam
Electrode Tines Retaining Disk:
1/32” white polyethylene foam (No patient contact)Both sides coated with medical-grade adhesive
Basepad: 1/16” white polyethylene foamBoth sides coated with medical-grade adhesive
Liner Card: Silicone-coated high impact polystyrene (No patient contact)
Packaging: Paper/aluminum foil/polyethylene (No patient contact)
ConforMS To STanDarDS:
ANSI/AAMI EC12:2000 – Disposable ECG Electrodes
ISO 10993-1:2003 – Biological evaluation of medical devices –
Part 1: Evaluation and testing (ISO 10993-1: 2009 also applies)
IEC 60601-1
PoTaSSIuM ChlorIDE ElECTroDE GEl:
Ingestion: No hazard in small quantities
Skin contact: No hazard
Inhalation: No hazard
Eye protection: Not required – as with cosmetics, avoid
eye contact
Emergency and First Aid Procedures: Handle as gelled water
Material Safety Data Sheet (MSDS) not required for “articles”
which have end use function as per OSHA Hazard
Communication Standard: 29 CFR 1910.1200
Single-use only
Latex free
Lead free
Nitrile free
PVC free
DEHP free
BIS™ bilateral sensor**
Lets you detect hemispheric differences in the brain, which may be useful for advanced monitoring applications.
Part number 186-0212, box of 10**Not compatible with BIS™ 2-channel systems. BIS™ LOC 4-channel cables required.
BIS™
Bilateral SensorTechnical Data Sheet
ParameterDescription
Sensor dimensions:8.75” x 7.75” (approx.)
Weight:10.5 g (approx.)
Weight (packaged):28.9 g (approx.)
Packaging:10 individually packaged sensors per box
Shelf Life:One and a half years from date of manufacture
Sensor ElementMaterial Description
Connector (Paddle):Polycarbonate plastic (Incidental patient contact)
Tab Stiffener:Polycarbonate sheet (No patient contact)One side coated with adhesive
Module:Copper/brass/Kapton (No patient contact)
Flexible Circuit:Polyester screen-printed with cured Ag/AgCl and dielectric inks (Incidental patient contact)
Electrode Gel:Potassium Chloride (KCl) aqueous gel
Electrode Tines Disk: Green nylon plastic
Electrode Sponge Disk:Polyurethane/polyester foam
Electrode Tines Retaining Disk:
1/32” white polyethylene foam (No patient contact)Both sides coated with medical-grade adhesive
Basepad:1/16” white polyethylene foamBoth sides coated with medical-grade adhesive
Liner Card:Silicone-coated high impact polystyrene (No patient contact)
Packaging:Paper/aluminum foil/polyethylene (No patient contact)
ConforMS To STanDarDS:
ANSI/AAMI EC12:2000 – Disposable ECG Electrodes
ISO 10993-1:2003 – Biological evaluation of medical devices –
Part 1: Evaluation and testing (ISO 10993-1: 2009 also applies)
IEC 60601-1
PoTaSSIuM ChlorIDE ElECTroDE GEl:
Ingestion: No hazard in small quantities
Skin contact: No hazard
Inhalation: No hazard
Eye protection: Not required – as with cosmetics, avoid
eye contact
Emergency and First Aid Procedures: Handle as gelled water
Material Safety Data Sheet (MSDS) not required for “articles”
which have end use function as per OSHA Hazard
Communication Standard: 29 CFR 1910.1200
Single-use only Nitrile free
Latex free PVC free
Lead free DEHP free
BIS™ pediatric sensor*
Measures brain activity in pediatric patients.
Part number 186-0200, box of 25*Ages four and up recommended.
BIS™
Pediatric XP SensorTechnical Data Sheet
Parameter Description
Sensor dimensions: 10.5” x 1.1” (approx.)
Weight: 3.2 g (approx.)
Weight (packaged): 16.3 g (approx.)
Packaging: 25 individually packaged sensors per box
Shelf Life: One and a half years from date of manufacture
Sensor Element Material Description
Connector (Paddle): Polycarbonate plastic (Incidental patient contact)
Tab Stiffener: Polycarbonate sheet (No patient contact)One side coated with adhesive
Module: Copper/brass/Kapton (No patient contact)
Flexible Circuit: Polyester screen-printed with cured Ag/AgCl and dielectric inks (Incidental patient contact)
Electrode Gel: Potassium Chloride (KCl) aqueous gel
Electrode Tines Disk: Green nylon plastic
Electrode Sponge Disk: Polyurethane/polyester foam
Electrode Tines Retaining Disk:
1/32” white polyethylene foam (No patient contact)Both sides coated with medical-grade adhesive
Basepad: 1/16” white polyethylene foamBoth sides coated with medical-grade adhesive
Liner Card: Silicone-coated high impact polystyrene (No patient contact)
Packaging: Paper/aluminum foil/polyethylene (No patient contact)
ConforMS To STanDarDS:
ANSI/AAMI EC12:2000 – Disposable ECG Electrodes
ISO 10993-1:2003 – Biological evaluation of medical devices –
Part 1: Evaluation and testing (ISO 10993-1: 2009 also applies)
IEC 60601-1
PoTaSSIuM ChlorIDE ElECTroDE GEl:
Ingestion: No hazard in small quantities
Skin contact: No hazard
Inhalation: No hazard
Eye protection: Not required – as with cosmetics, avoid
eye contact
Emergency and First Aid Procedures: Handle as gelled water
Material Safety Data Sheet (MSDS) not required for “articles”
which have end use function as per OSHA Hazard
Communication Standard: 29 CFR 1910.1200
Single-use only
Latex free
Lead free
Nitrile free
PVC free
DEHP free
BIS™ extend sensor (extended use)Measures brain activity in adult patients who require longer periods of monitoring, including those in the ICU.
Part number 186-0160, box of 25
BIS™
Extend SensorTechnical Data Sheet
Parameter Description
Sensor dimensions: 11” x 1.1” (approx.)
Weight: 3.7 g (approx.)
Weight (packaged): 16.8 g (approx.)
Packaging: 25 individually packaged sensors per box
Shelf Life: One and a half years from date of manufacture
Sensor Element Material Description
Connector (Paddle): Polycarbonate plastic (Incidental patient contact)
Tab Stiffener: Polycarbonate sheet (No patient contact)One side coated with adhesive
Module: Copper/brass/Kapton (No patient contact)
Flexible Circuit: Polyester screen-printed with cured Ag/AgCl anddielectric inks (Incidental patient contact)
Electrode Gel: Potassium Chloride (KCl) aqueous gel
Electrode Tines Disk: Green nylon plastic
Electrode Sponge Disk: Polyurethane/polyester foam
Electrode Tines Retaining Disk:
1/32” white polyethylene foam (No patient contact)Both sides coated with medical-grade adhesive
Basepad: 1/16” white polyethylene foamBoth sides coated with medical-grade adhesive
Liner Card: Silicone-coated high impact polystyrene (No patient contact)
Packaging: Paper/aluminum foil/polyethylene (No patient contact)
ConforMS To STanDarDS:
ANSI/AAMI EC12:2000 – Disposable ECG Electrodes
ISO 10993-1:2003 – Biological evaluation of medical devices –
Part 1: Evaluation and testing (ISO 10993-1: 2009 also applies)
IEC 60601-1
PoTaSSIuM ChlorIDE ElECTroDE GEl:
Ingestion: No hazard in small quantities
Skin contact: No hazard
Inhalation: No hazard
Eye protection: Not required – as with cosmetics, avoid
eye contact
Emergency and First Aid Procedures: Handle as gelled water
Material Safety Data Sheet (MSDS) not required for “articles”
which have end use function as per OSHA Hazard
Communication Standard: 29 CFR 1910.1200
Single-use only
Latex free
Lead free
Nitrile free
PVC free
DEHP free
Talk to your Medtronic representative to order BIS™ monitors and sensors, or visit medtronic.com/covidien
6. White PF, Ma H, Tang J, et al. Does the use of electroencephalographic bispectral index or auditory evoked potential index monitoring facilitate recovery after desflurane anesthesia in the ambulatory setting? Anesthesiology. 2004;100:811-817.
7. Myles PS, Leslie K, McNeil J, et al. Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomized controlled trial. Lancet. 2004;363:1757-1763.
8. Avidan MS, Zhang L, Burnside B, et al. Anesthesia awareness and the bispectral index. N Engl J Med. 2008;358:1097-1108.
9. Avidan MS, Jacobsohn E, Glic D, et al. Prevention of intraoperative awareness in a high-risk surgical population. N Engl J Med. 2011;365:591-600.
10. Ekman A, Lindholm ML, Lennmarken C, et al. Reduction in the incidence of awareness using BIS monitoring. Acta Anaesthesiol Scand. 2004;48:20-26.