Design Output
HumaStar 80
1 Title............................................................................................................................................................................ 2
2 Purpose ..................................................................................................................................................................... 2
3 Area of Application ................................................................................................................................................... 2
3.1 Delivery Format ................................................................................................................................................................... 2
3.2 Service Manual .................................................................................................................................................................... 2
3.3 Spare Parts List ..................................................................................................................................................................... 2
4 Referenced Documents ............................................................................................................................................ 2
5 Specifications ............................................................................................................................................................ 3
6 Classification and Dangerous Goods Aspects ......................................................................................................... 5
7 Storage ...................................................................................................................................................................... 5
8 Release, On hold ....................................................................................................................................................... 5
2.1 Description of Test Methods ........................................................................................................................................... 5
2.2 QC Specifications for Product Release.......................................................................................................................... 5
9 Maintenance ............................................................................................................................................................. 5
9.1 General remarks .................................................................................................................................................................. 5
9.2 Maintenance Procedure.................................................................................................................................................... 5
9.3 Safety recommendations ................................................................................................................................................. 5
10 Documentation ......................................................................................................................................................... 5
11 Attachment (CoA) ..................................................................................................................................................... 6
Form: 4.2-01.06-02 1/6
Rev. 005 | valid of 30.06.2011
1. Title
Design Output und product specification for the HumaStar 80.
2. Purpose
To specify the HumaStar 80 in its design and function.
3. Area of Application
The HumaStar80 is an automatic Clinical Chemistry Analyzer specially designed and developed to perform clinical
chemistry tests. The instrument performs spectroscopic measurements at preset wavelengths of analyze
concentrations and enzyme activities using various reagents. It can perform any combination of tests up to 54
samples per work plan. The analyzer automatically performs all reagent and sample pipetting, incubations,
photometric measurements and calculations. Programming and operating the analyzer is simple and made easy by
Windows ™. The software, which is supplied with the analyzer, should be installed on a PC connected to the
instrument.
The software allows to program and permanently store the tests in the PC memory, up to 9 test profiles, calibrators
and controls. Routine work plans are created by assigning patient´s data and tests and/or profiles to sample.
The analyzer can perform end-point (one or two reagents, monochromatic or dichromatic), differential mode, fixed
time and kinetic mode measurements. Calibration can be made using a factor or using calibrators. Up to nine
standards/calibrators can be programmed.
Samples can be distributed in up to three racks containing 24, 18, 12 positions each. Up to 20 reagents (plus 1
container for dilution) can be distributed in one row.
Quality control results can be permanently stored and can be examined as a list or chart format.
3.1 Delivery Format
The instrument is delivered in 1 (one) box containing:
Quantity Description Cat.-no.:
1 Analyzer 116880
1 Control unit HS 80 (PC) 18991P
1 Sheet with instructions for unpacking
Box containing accessories
Contents of box:
2 Reagent tray 16885/52
1 Sample tray 16885/511
40 Reagent bottles of 45 ml with caps 16885/53
40 Reaction wells segment 16885/54
500 Sample cup of 1.2 ml 16885/55
20 Kodak cup for the R2- of 2,5ml 16885/202
1 Halogen lamp 12V 20W 16885/48
2 Fuses of 5 A 18750/14
1 Standard power cables 18999
1 Tube kit
1 Wash station 16885/59
1 CD software 16880/4
1 HumaStar80 User manual 16880/1
1 Setting CD 16880/4S
3.2 Service Manual
The Service Manual is available with Cat. # 16880/2
3.3 Spare Parts List
A separate Spare Parts List is available with Cat. # 18960
4 Referenced Documents
User Manual, Service Manual, Spare Parts List, Warranty Guidelines, written QC procedure
Design Output for HumaStar 80 2/6
Rev. 005
5. Specifications
General characteristics
Processing capacity: up to 54 positions (including samples, calibrators and controls) per tray in a work
plan.
Incubation 1: 21 to 9999 s
Incubation 2: 0 to 180 s
Unlimited replicates for blanks, calibrators and samples
Calibration storing
Patient data (name, age, sex, etc. ) files – demography data base
QC
Sample tray
Sample cup capacity: 1.2 ml maximum
Tray capacity: 54 cups for samples, calibrators and controls
Reagent tray
Tray capacity: 20 reagent bottles of about 45 ml
Reaction wells
12 rows with 12 wells each
Reaction well capacity: 1 ml maximum
Reservoirs
Wash bottle: 0.5 l
Waste bottle: 0.5 l
Option: external waste tank
Programming
Tests: unlimited
Profiles: Up to 9 with an unlimited number of tests
Calibrators
Controls
Filters
Reagents
Analysis modes
End point: 1 or 2 reagents
Differential
Fixed time
Kinetic
Multi Standard
Kinetic analysis
Absorbance measurements during the programmed interval
Linearity evaluation
Use of factor or calibrator
Calibration types
Factor
Single calibrator: for one test (specific) or common to several test (multiple)
Calibration curve
Calibration curve
Up to 8 standards
Axes: Linear and Logarithmic
Calculation functions: Spline, Linear Regression, Square Regression, Polygonal
Design Output for HumaStar 80 3/6
Rev. 005
Quality Control
Analytical limits Control: Blank, Linearity, Factor
Up to 3 control materials per test
Levey-Jennings charts/shewart
Sample and reagent dispensing
One single syringe pipetting up to 1000 µ (positive displacement), 1/16 µl steps
Sample volume range: 2 to 200 µl in 1/16 µl steps
Reagent 1 volume range: 30 to 1000 µl in 1/16 µl steps
Reagent 2 volume range: 0 to 1000 µl in 1/16 µl steps
Liquid detection: resistance Sensor
Temperature control
3 thermostated areas
Reagent pre-warmed in the transfer arm (+/-1°C)
Reaction mixture thermostated in the reaction wells to 37°C ± n2°C
Reaction mixture thermostated in the flow cuvette to 37°C ± 0.2°C
Optical system
Principle: interference filter
Readings: monochromatic or dichromatic
Filters wheel with up to 8 filters and automatic filter selection
Light source: halogen lamp (12 V and 20 W)
Detector: Silicon Photodiode
Absorbance range: -0.200 to 2.500 O. D.
Spectral range: 320 to 690 nm
Wavelength error: ± 2 nm
Bandwidth: 8 ± 2 nm
Resolution: 0.0001 O. D.
Imprecision : CV<1% @ 2.0 OD
Transfer system
Continuous flow system, with peristaltic pump
Capacity of the flow-through cuvette: 18 µl
Automatic calibration
PC minimum requirement
The instrument should be connected a Personal Computer which needs the following requirements:
Processor 2GHz
256 Mbytes RAM
Hard disk capacity> 20 GBytes
Operating system: Windows™ 98, XP or Windows™ 7
o For usage with Windows™ 7 use HS80 software version h1.12e or later)
Drive for 3.5” 1.44 Mbytes disks
CD-ROM
Built-in network adapter
Output: Serial port
External printer
Physical dimensions
Instrument without any components: 72 x 73 x 45 cm
Space required for routine use: 105 x 93 x 85 cm
Packaging: 87 x 86 x 89 cm
Weight: Gross 79 kg, Net 42 kg
Electrical requirements
115/230 VAC (±15%) (autosense)
50/60 Hz
350 VA
Design Output for HumaStar 80 4/6
Rev. 005
Assistance to users
Automatic selection of the calibrators and controls required for a work plan
Automatic selection of the reagents required for a work plan
Dialogue screens (Windows) for programming, preparing work plans, presenting reports, etc.
Automatic alert messages on the screen
Graphics
Calibration and Kinetic curves
Quality Control (Levey-Jennings)
6. Classification and Dangerous Goods Aspects
The instrument complies with the European regulations for in vitro diagnostic medical devices (98/79/EC ) and
bears the CE mark.
7. Storage
Store instrument at temperature -10 ... 50°C and humidity less than 80% relative humidity, non-condensing.
8. Release, On hold
8.1 Description of Test Methods
Tests are performed by the quality control department according to written procedures.
Prior to each shipment randomly selected samples are subjected to a function test employing reagent kits and
serum samples.
Secondary packaging components are tested for correct amount, cleanness and suitability. Only released secondary
packaging components are employed for shipment.
8.2 QC Specifications for Product Release
Specification Result (tolerated range)
Results with control material within the 2 SD range
Software / PC connection Self Test o.k.
Mechanics Self Test o.k.
Photometer Self Test o.k.
9. Maintenance
9.1 General remarks
Please follow carefully the instructions for maintenance as given in the User Manual.
9.2 Maintenance Procedure
The exterior of the instrument may be cleaned with a soft cloth using plain water. If needed, a mild all-purpose
(nonabrasive) cleaner may be used. A 1.5% solution of chlorine bleach or 70% isopropyl alcohol may be used as a
disinfectant. Take special care not to spill any liquids onto the photometer section.
9.3 Safety recommendations
The detailed installation procedure as well as safety and precaution remarks are described in the User Manual.
Before installation and operating the system, the User Manual has to be carefully read by the user.
10. Documentation
Documents and protocols are retained for the regulatory defined periods, respectively for the period defined by
HUMAN’s quality management system (SOP 4.2-01).
Design Output for HumaStar 80 5/6
Rev. 005
11. Attachment (CoA)
HumaStar 80 Cat. No.: 16880
Serial No. xxxx
Invent. date: YYYY-MM
Description
Automated clinical chemistry batch analyzer
Storage Conditions: Store at ambient conditions!
QUALITY SPECIFICATIONS
1. Contents: Complete acc. pack list Within Specification
2. Function test Test according to intern SOP Within Specification
This product passed the quality control release criteria and has been released by the responsible Quality
Control Department of HUMAN GmbH.
Following release of the product, this certificate of analysis is electronically regenerated and valid
without signature.
Date of print: dd.mm.yyyy
Design Output for HumaStar 80 6/6
Rev. 005
