BIONIME GM550 Manual de usuario descargar pdf (Pagina 25)

Customer Service

We sincerely like to provide complete, considerate services to our customers. Please review all the

instructions to make sure you are performing the steps correctly. If you have any questions or in case

of problems with the products, please contact your local Bionime customer

service.

Rightest GM550

For in vitro diagnostic use

Temperature limitation

Manufacturer

LO T

IV D

Lot number

Expiry date

For single use only

Method of sterilization using irradiation

REP

EC Representive

Consult the instruction for use

CE-mark (with No. of notified body)

Description of used symbols

Accuracy

Difference range in values

between the Olympus value

and the Rightest™ meter

value

Within ± 5%

Within ± 10%

Within ± 15%

Within ± 20%

The percent ( and number ) of samples for which the difference between the

Rightest™ meter value and the Olympus value were within the difference range

shown in the side row.

Table 2: represents samples for glucose results greater than 75 mg/dL.

* Acceptance criteria in ISO15197 are that 95% of all differences in glucose values should be within ±15 mg/dL for

glucose values less than 75 mg/dL, and within ±20% for glucose values greater than 75 mg/dL.

Note: When glucose meter results are compared to the laboratory results, difference values below 75 mg/dL are

expressed in mg/dL, while those above 75 mg/dL are compared in percent.

Fingertip

55.8% (53/95)

75.8% (72/95)

91.6% (87/95)

96.8% (92/95)

Palm

55.8% (53/95)

75.8% (72/95)

89.5% (85/95)

96.8% (92/95)

Forearm

49.5% (47/95)

71.6% (68/95)

91.6% (87/95)

97.9% (93/95)

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BIONIME GM550 Manual de usuario Pagina 25

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