Abbott Precision Xceed Pro Uživatelský manuál stáhnout pdf (Strana 5)

Bedside glucose testing systems

LifeScan Inc. Medtronic MiniMed Inc.

Healthcare Professional Line 18000 Devonshire St.

1000 Gibraltar Dr., Milpitas, CA 95035-6312 Northridge, CA 91325

800-524-7226 800-646-4633

Part 5 of 7

www.lifescan.com www.minimed.com

Name of instrument/First year sold

SureStep Flexx/2000 iPro Continuous Glucose Monitor (CGM)/2008

Professional or home use

professional use professional use

List price

$1,200 with bar-code scanner/$1,300 with bar-code scanner, meter

unlock, and bar-code scan required features/$850 without bar-code

scanner

$1,299 for iPro Professional Starter Kit, $899 for iPro Recorder/Charger

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

>44,000/>4,000/>3,000 —

Part of series of similar or related models

yes yes (third-generation professional CGM system)

Dimensions (H x W x D)/Weight

6.34 × 3.55 × 1.63 in/12.5 oz (with bar-code scanner), 12.1 oz (without) .37 × 1.40 × 1.12 in/<5 grams

Analytical method/Technology/Enzyme system used

reﬂectance photometry/glucose oxidase glucose oxidase

Price per disposable reagent system unit

by contract, volume $35 unit glucose sensor (disposable)

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

Two 25-strip vials (50 strips per box) 10 per box, 4 per box

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

1 each sensor is indicated for 72-hour use

Dispos. units shelf life/Reag. unit storage requirements

18 months unopened/<30°C (86°F); away from heat, direct sunlight 6 months/non-refrigeration 36°–80°F (2°–27°C)

Digital readout size/Keypad input capability

18-point font (16 pixels high, 8 pixels wide)/menu select., numeric,

alphabetic

no patient monitor interface/blinded glucose values, retrospective data

How results are displayed

true values data is downloaded from iPro Recorder to computer; CGM reports viewed

through ofﬁce computer or printed, or both

Specimen types/Sampling techniques

whole blood (capillary, venous, arterial, neonatal)/drop, capillary transfer,

touchable strip, off-meter dosing

continuous monitoring and sampling of interstitial ﬂuid glucose levels

Minimum specimen volume required

5 µL, maximum 30 µL —

Suitable for samples from well/Sick neonates

yes/yes no/no (indicated for age 7+)

Time from sample intro. to result availability

15-second minimum retrospective analysis after disconnection

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

AA/3/1,000 test minimum rechargeable battery, iPro CGM charger, AAA/1/—

Avg. expected life of device/Mean time between failures

5-year minimum/<10% warranty return rate 1 year/—

Device warranty/Service options

1 year/extended service agreements available 6 months for iPro Recorder/no warranty on disposables

Loaners provided

24-hour replacement with new device no

User list or user group

yes (contact SureStep Flexx product manager) no

Toll-free No. for customer questions/Hours

800-524-7226/24 hours, 7 days, multiple languages 800-646-4633/5am–5pm PST

Training and certif. program/No. training days provided

yes/as negotiated yes (training only)/~1 day

Avg. time for lab to complete maintenance

<1 minute none

Special cleansing procedures

no no

Internal QC recommended or required

as deﬁned by hospital policy none

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

• <50 mg/dL

2.5% —

• 100–200 mg/dL

2.9% 5% (40–400 mg/dL) in vitro

• >400 mg/dL

2.4% —

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

data from 2000 & 2001 AACC posters CGMS 1999, CGMS Gold 2003, iPro CGM 2008

Accuracy/Compared to what reference method or device

r>0.98/YSI coefﬁcient of variation (CV) of 5%/ﬁngerstick blood glucose

measurements

Precision/Compared to what reference method or device

3.44–4.97 CV across runs/— —/home glucose meters

Linear range

0–500 mg/dL —

Suggested dynamic, measurement range

0–500 mg/dL 40–400 mg/dL

Contraindications

excessive water loss or dehydration no

Known interferences/High-altitude interference

sodium ﬂuoride/no possibly MRI/no

Restrictions based on hematocrit

adults: 25%–60%; neonates: 25%–65% no

Electronic, optical function checks

automatic electronic and optical checks with each test test plug

Sample quantity checks

test strip color conﬁrmation dot when adequate sample applied; meter

error messages

none

When auto lock or shutdown occurs

user ID failure, QC failure, failure to transfer data none

User deﬁnes QC lockout intervals/Lockout can be circumvented

yes/yes, automatic meter unlock feature requires no user intervention no/no

Device supports bar-code scanning of

operator & patient identiﬁers, reagent (strip) lot Nos., control solution lot

Nos., meter serial Nos.

no bar-code scanner

Method of analyst ID/ID required

unique alphanumeric ID/optional (deﬁned by location) at time of monitor download/optional

Internal memory size/Max. No. patient results stored

256 KB/1,500 patient +QC tests, 50-test strip lots and 50 QC lots up to 14 days continuous data/288 readings per day

Information transfer capability:

• Meters connect to

OneTouch DataLink data management system via wireless network,

network and modem connectivity solutions. OneTouch DataLink can be

interfaced with LIS/HIS

iPro Recorder and meters upload data to ofﬁce computer

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

No. installations

OneTouch DataLink Connect connectivity solutions; wireless/network,

modem connectivity/1,400 hospital sites, DataLink Interface >600

iPro Recorder wirelessly transmits to ComLink, which connects via serial

port or USB; meters connect via serial port or USB depending on meter

• Info. contained in transmission to external system

device unique identiﬁers, operator & patient IDs, results, QC identiﬁers,

result ﬂags, location/site

sensor values, meter values and events (meals, insulin, exercise, and

other)

Hardware/software for data mgmt. system

hardware-independent/OneTouch DataLink data management system in-

stallation CD for Windows Vista & XP Pro; Telcor QML; OneTouch DataLink

Web using Microsoft Windows Server 2003/2008

ComLink for iPro CGM/Solutions software installed on the ofﬁce

computer

No. of different mgmt. reports system can produce

12 standard, unlimited customized reports, TGC advisor 5 standard unlimited customized reports

Contents downloaded from DMS to meter

strip lot Nos., valid control values, valid operator IDs, critical value

ranges, comment codes

—

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

does not interface LIS or HIS, a report from software–nontransferable

• using screen animation/screen scraping

Cerner Citation, Cerner Classic, Cerner Premier, CHCS, HMS, McKesson

ALG, McKesson Star Financial, McKesson Star Lab, Meditech Magic,

RPMS, Sunquest, SoftLab Non-GUI, VistA

• using standard HL7 interface

Cerner Classic, Cerner Millennium, CPSI, Eclypsis, EPIC, Iatrics, McKesson

Horizon Lab, McKesson Paragon, McKesson Horizon Clinicals, Mediserve,

MediSolutions, Meditech Client Server, Meditech Magic, Meditech

MagicHCA, Sunquest, Sunquest IGO, Omnetech, OpusLab, Siemens

Invision, Siemens Novius Lab, Siemens LCR, SoftLab, TripleG, VistA,

Repositories and Engines

• using proprietary protocol interface

none no

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

yes, Telcor QML no

Distinguishing features (provided by vendors)

no risk of interference from maltose, xylose, or galactose; off-meter

dosing helps with infection-control policies; conﬁgurable bar-code

scanning options—allows truncation of leading and trailing characters;

bar-code scan required feature; unique meter unlock; hardware-

indepen. OneTouch DataLink data mgmt. software; wireless connectivity;

compatible w/Telcor’s QML; ﬂexible database options; Citrix support

continuous glucose values every 5 minutes; limited patient education

required with no additional device/receiver for patient to carry around;

easy-to-read reports generated from ofﬁce computer

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

February 2010 CAP TODAY / 21

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