Abbott Precision Xceed Pro Manual de usuario descargar pdf (Pagina 7)

24 / CAP TODAY February 2010

Bedside glucose testing systems

Roche Diagnostics YSI Life Sciences

Accu-Chek Customer Care Service Center

Jamie Lussier [email protected]

9115 Hague Rd., Indianapolis, IN 46256 1725 Brannum Lane, Yellow Springs, OH 45387

800-440-3638 800 659-8895

Part 7 of 7

www.roche-diagnostics.us www.ysilifesciences.com

Name of instrument/First year sold

Accu-Chek Inform System/2001 YSI 2300 STAT Plus Glucose & Lactate Analyzer/1989

Professional or home use

professional use

List price

$1,200 $11,350

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

67,000/10,000/— —

Part of series of similar or related models

yes yes

Dimensions (H x W x D)/Weight

1.4 × 3.8 × 7.6 in/12 oz 35.6 × 35.6 × 25.4 cm/25 lbs. (11.4 kg)

Analytical method/Technology/Enzyme system used

biosensor—glucose dehydrogenase enzyme electrode, hydrogen peroxide, glucose oxidase

Price per disposable reagent system unit

contingent on contract price $15 per membrane sensor (cost per test: $0.14 @ 2,000 patient samples)

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

50 test strips 4 membranes per package

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

1 time based 3 weeks, 1000+ patient samples

Dispos. units shelf life/Reag. unit storage requirements

18 months, stable until expiration date on vial/room temperature less

than 90°F, do not freeze

1 year/liquid reagents: room temp.; membrane sensor: 4°C refrigerated

Digital readout size/Keypad input capability

font size varies/menu selection, numeric, alphabetic font hgt: 0.2 in., 2 x 40 alphanumeric LCD/menu selection, numeric

How results are displayed

true values true and calculated values

Specimen types/Sampling techniques

whole blood/arterial, venous, capillary, neonate (including cord blood) plasma, serum, whole blood/probe aspirated 25 µL

Minimum specimen volume required

4 µL 35–50 µL, dependent upon tube style

Suitable for samples from well/Sick neonates

yes/yes yes/yes

Time from sample intro. to result availability

26 seconds 65 seconds

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

3.7 V rechargeable lithium ion/1/testing in progress AC line power/—/—

Avg. expected life of device/Mean time between failures

5 years/542,000 tests 10 years+/unknown

Device warranty/Service options

Accu-Chek Inform System will be free from defects in materials & work-

manship through life of the Accu-Chek Comfort Curve test strip contract;

overnight replacement, according to warranty policy, is available 24/7,

365 days per year

1 year/on all parts and labor/on-site service, dealer service centers,

manufacturer service center in Ohio

Loaners provided

replaced under warranty yes

User list or user group

yes (contact local account manager) no (YSI 2300 is a reference blood instrument)

Toll-free No. for customer questions/Hours

800-440-3638/24 hours, 365 days per year yes/8 a m -5 p m EST USA

Training and certif. program/No. training days provided

yes/site-speciﬁc according to No. of employees yes/onsite: 1 day; vendor ofﬁce: negotiable

Avg. time for lab to complete maintenance

none daily: 15 min (calibration and check solution sample); weekly: 30 min

(buffer solution change); monthly: 30 min (calibration solution and buffer

solution change)

Special cleansing procedures

acceptable active ingredients: water, soap, 70% (or less) isopropyl alco-

hol, 1:10 dilution of sodium hydrochlorite

Internal QC recommended or required

daily, 2 levels of glucose control solutions run a daily third-party control, such as a serum control

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

• <50 mg/dL

53.8 mg/dL SD=4.1 (6,088 labs) 2.5 mg/dL*

• 100–200 mg/dL

191.4 mg/dL CV=4.7% (3,096 labs) 2%*

• >400 mg/dL

228.5 mg/dL CV=4.6% (6,099 labs) 2%*

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

CAP, 2001/WBG-C/see above —

Accuracy/Compared to what reference method or device

y=0.991 x + 8.4, r=0.980/glucose hexokinase–Hitachi YSI enzyme electrode technology commonly used whole blood glucose

standard; YSI 2300 used as reference method for blood glucometer

development and glucometer test strip QA

Precision/Compared to what reference method or device

controls: low SD=2.83 mg/dL, mid CV=3.08%, high CV=2.82%; blood: low

SD=1.5 mg/dL, mid CV=3.2%, high CV=3.2%/glucose hexokinase

hexokinase/UV spectrophotometric compared to plasma

Linear range

10–600 mg/dL glucose: 0 to 900 mg/dL (9,000 mg/L, 50.0 mmol/L)

Suggested dynamic, measurement range

10–600 mg/dL glucose: 0 to 900 mg/dL (9,000 mg/L, 50.0 mmol/L)

Contraindications

yes, per labeling no

Known interferences/High-altitude interference

per labeling/none up to 10,150 ft none that are biological in nature/no

Restrictions based on hematocrit

yes, glucose <200 mg/dL 20%–65%; glucose >200 mg/dL 20%–55% no

Electronic, optical function checks

meter with code key, battery voltage test, internal database memory

check, internal conﬁguration check

— (sensor technology is amperometric, not optically based)

Sample quantity checks

built-in electronic strip check, visible veriﬁcation of sample volume —

When auto lock or shutdown occurs

user ID failure (valid op.), QC failure, download interval lockout, patient

ID length, reagent editing, mandatory comments, incorrect/missing code

key, time, and data editing

calibration instability, low reagent levels, various electromechanical

checks related to moving parts

User deﬁnes QC lockout intervals/Lockout can be circumvented

yes/no (optional QC pass/fail feature) —

Device supports bar-code scanning of

operator & patient identiﬁers, reagent lot Nos. no bar-code scanner

Method of analyst ID/ID required

alphanumeric or bar-code scan/yes numeric identiﬁer optional/optional

Internal memory size/Max. No. patient results stored

4,000 results/4,000 tests —/last 32 results stored in internal buffer accessible by serial port

Information transfer capability:

• Meters connect to

information management system, which in turn connects to LIS/HIS — (requires customized software for LIS/HIS interface)

• 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 & patient IDs, results, strip lot Nos.,

QC identiﬁers, proﬁciency & linearity samples, comments, meter location,

download location

—

Hardware/software for data mgmt. system

MAS RALS-Plus, MAS RALS-Lite*, MAS RALS-Notebook

†

, and

MAS RALS-Web

through custom software, patient ID and results may be retrieved

No. of different mgmt. reports system can produce

varies by Data Manager (customer deﬁned) —

Contents downloaded from DMS to meter

—

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

QC & strip lot Nos., valid control values, valid operator & patient IDs,

meter conﬁguration, linearity lot Nos. & values, comments

• using screen animation/screen scraping

all major LIS vendors including Cerner, Meditech, Misys, CPSI, SoftLab,

Siemens, McKesson, SIA Molis, Opus, others**

—

• using standard HL7 interface

yes —

• using proprietary protocol interface

—

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

MAS —

Distinguishing features (provided by vendors)

uses the Accu-Chek Comfort Curve test strip; universal sampling due

to oxygen-independent chemistry, with reliable results at varying

hematocrit levels; offers alphanumeric touchscreen, onboard bar-code ID,

and MAS RALS-Plus connectivity, including ADT feed, which provides two

patient identiﬁers for conﬁrmation; extends the quality of blood glucose

programs to six other point-of-care tests by allowing the entry and

transfer of manual test information

†

Roche exclusive

**both scripted/HL7 are available depending on LIS version

commonly used reference method for glucometers; ideal for hospital dia-

betes evaluation testing, for example, clamp studies; accurate stat whole

blood glucose 1-minute result

*based on YSI proof of claims testing

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

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