Abbott Precision Xceed Pro Manual de usuario

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Bedside glucose testing systems
Abbott Diabetes Care
1420 Harbor Bay Parkway
Alameda, CA 94502
510-749-5400
Part 1 of 7
www.abbottdiabetescare.com
Name of instrument/First year sold
Precision Xceed Pro Blood Glucose and Beta-Ketone Monitoring System/2007
Professional or home use
professional and home use
List price
Units sold in U.S./Outside U.S./In 2009
Part of series of similar or related models
yes
Dimensions (H x W x D)/Weight
19.7 cm (7.7 in) × 7.5 cm (2.96 in) × 5.33 cm (2.1 in)/256 g (9 oz)
Analytical method/Technology/Enzyme system used
glucose-specific GDH-NAD enzyme and low applied voltage to minimize
interference; beta-hydroxybutyrate, the predominant blood ketone DKA
Price per disposable reagent system unit
No. of dispos. reag. system units per basic package
glucose: 100 strips; ketone: 50 strips
No. of times analyses performed using 1 reag. system unit
1
Dispos. units shelf life/Reag. unit storage requirements
15–18 months/4°–30°C
Digital readout size/Keypad input capability
3.06 mm (normal), 8.16 mm (results)/menu selection, numeric, alphabetic
How results are displayed
true values
Specimen types/Sampling techniques
whole blood/drop, capillary transfer, touchable strips
Minimum specimen volume required
glucose: 0.6 µL; ketone: 1.5 µL
Suitable for samples from well/Sick neonates
yes/yes
Time from sample intro. to result availability
glucose: 20 seconds; ketone: 10 seconds
Batteries used/No. used/Avg. life of one set
AA or NiMH rechargeable/2/—
Avg. expected life of device/Mean time between failures
Device warranty/Service options
1 year, lifetime replacement with reagent contract/24-hour replacement
Loaners provided
yes
User list or user group
yes, list available upon request
Toll-free No. for customer questions/Hours
877-529-7185/24 hours, 7 days
Training and certif. program/No. training days provided
yes/depends on number of operators
Avg. time for lab to complete maintenance
none
Special cleansing procedures
no
Internal QC recommended or required
as defined by facility or institutional policy
Between instrument CV (based on PT) at these levels:
• <50 mg/dL
70.5 mg/dL, CV=5.0% (4,259 labs)
• 100–200 mg/dL
121.4 mg/dL, CV=4.9% (8,177 labs)
• >400 mg/dL
409.6 mg/dL, CV=4.8% (8,052 labs)
• Program name, year/Challenge No./Level of mean glucose challenge sample
CAP Whole Blood Glucose Survey, WBG-C, 2008/—
Accuracy/Compared to what reference method or device
capillary blood: y=0.94x + 1.6; r=0.98/YSI
Precision/Compared to what reference method or device
blood samples: CV 3.0% to 3.6%/YSI
Linear range
glucose: 20–500 mg/dL; ketone: 0.0–8.0 mmol/L
Suggested dynamic, measurement range
glucose: 20–500 mg/dL; ketone: 0.0–8.0 mmol/L
Contraindications
per labeling
Known interferences/High-altitude interference
per labeling/no
Restrictions based on hematocrit
yes, glucose: 20–70%; ketone: 30–60%
Electronic, optical function checks
battery, bar-code scanner, database, and temperature checks performed
during power-up of meter
Sample quantity checks
fill-trigger electrode on each test strip specifically designed to start the
test when sufficient sample is detected
When auto lock or shutdown occurs
user ID failure, QC failure
User defines QC lockout intervals/Lockout can be circumvented
yes/no
Device supports bar-code scanning of
operator & patient identifiers, reag. lot numbers, comment codes, control
and linearity lot Nos.
Method of analyst ID/ID required
bar-code or manual ID entry/analyst ID optional
Internal memory size/Max. No. patient results stored
1,000 control test results, 6,000 operators, 6,000 patient IDs, 2,500 patient
test results, 18 glucose test strip lots, 20 proficiency test results, 20 glucose
linearity test results (1 panel, 5 levels, 4 replicates per level)
Information transfer capability:
• Meters connect to
PrecisionWeb data management system, which in turn connects to LIS/HIS
How meters are connected to external system to upload results/
No. installations
direct serial, modem dial-in, hospital network/—
• Info. contained in transmission to external system
device unique identifiers, operator and patient IDs, results, QC identifiers,
strip lots, comment codes, test dates & times
Hardware/software for data mgmt. system
Enterprise multi-user Web-based system running on highly redundant Dell
server
No. of different mgmt. reports system can produce
25
Contents downloaded from DMS to meter
strip lot Nos., valid control values, valid operator IDs, patient list, QC lockout
and upload lockout parameters
System connected (live installations) to which LISs/HISs:
• using screen animation/screen scraping
Cerner, Misys, PerSe, Meditech, SoftLab, CPSI, Vista, CHCS, GE Medical,
ADAC, HBOC Star, McKesson Horizon Lab, Siemens Novius Lab
• using standard HL7 interface
Cerner, Misys, PerSe, Meditech, SoftLab
• using proprietary protocol interface
none
Use 3rd-party interfacing tool/engine for LIS/HIS interfaces
yes/Sybase
Distinguishing features (provided by vendors)
TrueID: technology to identify patients by name, gender, date of birth,
alphanumeric data entry; TrueMeasure: test-strip technology detects
adequate sample and minimizes chemical interference; TrueAccess:
notification and lock-out technology helps ensure compliance with
procedures
Tabulation does not represent an endorsement by the College of American Pathologists. Survey editor: Raymond Aller, MD
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Indice de contenidos

Pagina 1 - CAP TODAY

Bedside glucose testing systemsAbbott Diabetes Care1420 Harbor Bay ParkwayAlameda, CA 94502510-749-5400 Part 1 of 7www.abbottdiabetescare.comName of

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