Abbott Precision Xceed Pro Manual de usuario descargar pdf (Pagina 2)

16 / CAP TODAY February 2010

Bedside glucose testing systems

Arkray Inc. Arkray Inc.

5198 W. 76th St. 5198 W. 76th St.

Edina, MN 55439 Edina, MN 55439

800-818-8877 800-818-8877

Part 2 of 7

www.arkrayusa.com www.arkrayusa.com

Name of instrument/First year sold

Assure Platinum/2010 Assure Pro/2006

Professional or home use

professional use professional use

List price

— free with competitive trade out

Units sold in U.S./Outside U.S./In 2009

—/—/1 —

Part of series of similar or related models

yes yes

Dimensions (H x W x D)/Weight

4.5 × 2.5 × 1.2/2.8 oz 4.1 × 2.4 × 1 in/2.5 oz without battery

Analytical method/Technology/Enzyme system used

glucose oxidase glucose oxidase

Price per disposable reagent system unit

contact sales representative contact sales representative

No. of dispos. reag. system units per basic package

50 or 100 50 or 100

No. of times analyses performed using 1 reag. system unit

1 1

Dispos. units shelf life/Reag. unit storage requirements

18 months/room temperature 18 months/room temperature

Digital readout size/Keypad input capability

—/none —

How results are displayed

true values true values

Specimen types/Sampling techniques

whole blood/drop whole blood/capillary transfer

Minimum specimen volume required

0.5 µL 0.5 µL

Suitable for samples from well/Sick neonates

no/no no/no

Time from sample intro. to result availability

7 seconds 10 seconds

Batteries used/No. used/Avg. life of one set

AAA/2/5,000 tests with 4 tests per day 1.5 V alkaline AAA/2/up to 5,000 tests

Avg. expected life of device/Mean time between failures

— —

Device warranty/Service options

5 years/— 5 years/—

Loaners provided

yes yes

User list or user group

no no

Toll-free No. for customer questions/Hours

800-818-8877/24 hours, 7 days 800-818-8877/24 hours, 7 days

Training and certif. program/No. training days provided

yes/1 on-site yes/as needed

Avg. time for lab to complete maintenance

daily: <5 minutes weekly: 5 minutes

Special cleansing procedures

no no

Internal QC recommended or required

control solution testing as speciﬁed by accreditation

Between instrument CV (based on PT) at these levels:

• <50 mg/dL

— —

• 100–200 mg/dL

— —

• >400 mg/dL

— —

• Program name, year/Challenge No./Level of mean glucose challenge sample

— —

Accuracy/Compared to what reference method or device

slope=1.00, y-intercept= -2.33, r=0.99/YSI model 2300 slope=0.94, y-intercept=0.63, r=0.99/YSI glucose analyzer

Precision/Compared to what reference method or device

For glucose results ≥75mg/dL, 100% within ±20%; 96% within ±15%;

79% within ±10%; and 53% within ± 5%. For glucose results <75 mg/dL,

100% within ± 15mg/dL; 100% within ± 10 mg/dL; 88% within ± 5 mg/dL

For glucose results ≥75mg/dL, 100% within ±20%; 99% within ±15%;

91% within ±10%; and 66% within ± 5%. For glucose results <75 mg/dL,

100% within ± 15mg/dL; 100% within ± 10 mg/dL; 92% within ± 5 mg/dL

Linear range

20–600 mg/dL 20–600 mg/dL

Suggested dynamic, measurement range

20–600 mg/dL 20–600 mg/dL

Contraindications

yes, see labeling yes

Known interferences/High-altitude interference

yes/per labeling per labeling/no, tested up to 10,000 feet

Restrictions based on hematocrit

yes, 30%–55% yes, 30%–55%

Electronic, optical function checks

automatic automatic, electronic

Sample quantity checks

— —

When auto lock or shutdown occurs

— —

User deﬁnes QC lockout intervals/Lockout can be circumvented

— no/—

Device supports bar-code scanning of

no bar-code scanner no bar-code scanner

Method of analyst ID/ID required

— —

Internal memory size/Max. No. patient results stored

500/500 tests 250 tests with time & date stamp/250 test results

Information transfer capability:

• Meters connect to

— —

• How meters are connected to external system to upload results/

No. installations

— —

• Info. contained in transmission to external system

— —

Hardware/software for data mgmt. system

— —

No. of different mgmt. reports system can produce

— —

Contents downloaded from DMS to meter

— —

System connected (live installations) to which LISs/HISs:

• using screen animation/screen scraping

— —

• using standard HL7 interface

— —

• using proprietary protocol interface

— —

Use 3rd-party interfacing tool/engine for LIS/HIS interfaces

— no

Distinguishing features (provided by vendors)

auto coding, no need to manually code the meter; qcProGuard, a 24-hour

control solution reminder; strip-release button, no need to touch used

test strips

24-hour optional control solution reminder; top-of-meter strip insertion;

strip-release button; backlight display; new strip launched late 2009

Tabulation does not represent an endorsement by the College of American Pathologists.

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