0% found this document useful (0 votes)
2K views

Operating Manual: Diaspect TM

Uploaded by

Abdolkader Najeb
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
2K views

Operating Manual: Diaspect TM

Uploaded by

Abdolkader Najeb
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 28

DiaSpect Tm

Operating Manual
This document is protected by copyright.

It may not be reproduced or distributed to third parties


without the prior written consent of DiaSpect Medical GmbH.
Subject to alteration. Errors excepted.

DiaSpect Medical GmbH


Von-Cancrin-Str. 1
63877 Sailauf
Germany

Phone: +49 6093 996689-60


Fax: +49 6093 996689-66

Manual revision: GB-01-20160730


Released: 07/2016
DiaSpect Tm Operating Manual

Table of Contents

1. Intended Use...............................................................................................................................4
2. In Vitro Diagnostic Directive...............................................................................................4
3. Summary and Explanation of the Test..........................................................................4
4. Principles of the Procedure.................................................................................................4
5. The DiaSpect Tm Analyzer..................................................................................................5
5.1 Hemoglobin Measuring System......................................................................5
5.2 Consumables.............................................................................................................5
5.3 Control Material.......................................................................................................6
5.4 Installation and Operation..................................................................................7
5.5 Charging ....................................................................................................................8
5.6 Data Transfer.............................................................................................................9
5.7 Cleaning.......................................................................................................................9
5.8 Calibration and Control.......................................................................................10
5.9 Disposal........................................................................................................................11
5.10 Hazards........................................................................................................................12
5.11 Service and Maintenance....................................................................................13
6. Specimen Collection and Preparation ..........................................................................14
6.1 Capillary Sampling.................................................................................................14
6.2 Venous Sampling....................................................................................................16
6.3 Control Sampling....................................................................................................17
7. Measuring......................................................................................................................................18
8. Troubleshooting Guide.......................................................................................................... 19
9. Results ........................................................................................................................................20
10. Performance Characteristics .............................................................................................20
11. Technical Specifications........................................................................................................ 21
12. Limitations....................................................................................................................................22
13. References....................................................................................................................................22
14. Accessories..................................................................................................................................23
15. Spare parts...................................................................................................................................23
16. Symbols Used.............................................................................................................................24

3
DiaSpect Tm Operating Manual

1. Intended Use
The DiaSpect Tm system is designed for quantitative total hemoglobin
determination in human blood, using capillary, venous or arterial samples in a
specifically designed analyzer, the DiaSpect Tm, using specifically designed
disposable cuvettes, DiaSpect Hemoglobin Cuvettes.
The DiaSpect Tm analyzer is only to be used with DiaSpect Hemoglobin Cuvettes.
The DiaSpect Tm analyzer and the DiaSpect Hemoglobin Cuvettes are for in vitro
diagnostic use only. The DiaSpect Tm analyzer and the DiaSpect Hemoglobin
Cuvettes may only be used by professionals.

2. In Vitro Diagnostic Directive


The CE marked DiaSpect Tm analyzer complies with the Directive 98/79/EC on in vitro
diagnostic medical devices.

3. Summary and Explanation of the Test


The DiaSpect Tm system provides instant quantitative total hemoglobin results using
capillary, venous or arterial samples. The system is based on photometric
measurement of hemoglobin in unaltered whole blood and consists of a
photometer and cuvettes.

4. Principles of the Procedure


The DiaSpect Tm analyzer utilizes a broad-spectrum, multi-chromatic sensor with
compensation for turbidity and scattering which measures the absorbance of whole blood
over a wide spectral range. The hemoglobin concentration is calculated from the
measured absorbance at multiple wavelengths. The cuvettes do not contain any reagent.
The system is factory calibrated (and requires no further calibration) against the
hemoglobincyanide (HiCN) method, the international reference method for the
determination of hemoglobin concentration in blood as described in NCLLS H15-A3
and ICSH standard 1995. 1) 2)

4
DiaSpect Tm Operating Manual

5. The DiaSpect Tm Analyzer

5.1 Hemoglobin Measuring System


The DiaSpect Tm analyzer, manual, USB-cable, adapter plug and the power supply are
delivered in a carton.
Upon delivery, open the carton on a stable surface, remove the instrument and the
accessories, and check that all the components are included and undamaged.
Please contact the manufacturer or your local distributor for replacement spare parts if
anything is missing or damaged. A comprehensive list (with item numbers) of all
designated consumables and accessories for the Diaspect Tm can be found in section 14
and 15. The DiaSpect Tm analyzer can be stored at 0 °C to +50 °C (+32 °F to +122 °F).
Temperatures of -30 °C to +70 °C (-22 °F to +158 °F) are temporarily permitted
during transport (24 hours max.). Operating temperature is +10 °C to +35 °C
(+50 °F to + 95 °F). Allow the analyzer to reach ambient temperature before use.

1 2 3
1. DiaSpect Tm 2. Operating manual 3. Power supply, adapter
analyzer plug and USB cable

5.2 Consumables
DiaSpect Hemoglobin Cuvettes are packed in resealable bags containing 100 pieces,
5 bags per box. The disposable microcuvette requires <10 μL sample volume and serves
as sample collector and measuring cuvette at the same time.
Cuvettes are ready for use upon removal from the package. The blood sample is
drawn into the cavity by capillary force.

5
DiaSpect Tm Operating Manual

Store at 0 °C to +50 °C (+32 °F to +122 °F). Temperatures of -30 °C to +70 °C


(-22 °F to +158 °F) are temporarily permitted during transport (24 hours max.) as long as
the cuvettes are stored in their original packaging. Use the DiaSpect
Hemoglobin Cuvettes prior to the expiry date (the expiry date is the same for
unopened or opened bags). Unused cuvettes should be stored in their original bag.

DiaSpect Hemoglobin cuvettes

5.3 Control Material


The DiaSpect Control HBT can be stored unopened at +2 °C to +25 °C
(+35 °F to +77 °F).
Temperatures of -30 °C to +70 °C (-22 °F to +158 °F) are temporarily permitted
during transport (24 hours max.) as long as stored in the original packaging.
Do not expose the bottles to direct sunlight!
After opening, when properly recapped, the product is stable for 60 days when
stored at +2 °C to +35 °C (+35 °F to +95 °F).

Package configurations of DiaSpect Control HBT

DiaSpect Control HBT1 3 x DiaSpect Control HBT-Low

DiaSpect Control HBT2 3 x DiaSpect Control HBT-Medium

DiaSpect Control HBT3 3 x DiaSpect Control HBT-High

1 x DiaSpect Control HBT-Low


DiaSpect Control HBT4 1 x DiaSpect Control HBT-Medium
1 x DiaSpect Control HBT-High

Content: 1.9 mL per vial, 3 vials per package

6
DiaSpect Tm Operating Manual

5.4 Installation and Operation


Only qualified/trained personnel may use the DiaSpect Tm analyzer.
Please read the operating manual before using the analyzer for the first time.
The DiaSpect Tm analyzer comes ready for use. No installation procedure is
necessary. The display is always ON. The analyzer does not have an ON/OFF switch.
When not measuring, the analyzer remains in a low power mode.
The DiaSpect Tm analyzer may be used as a handheld device.

Understanding the DiaSpect Tm Display

Hemoglobin Unit of measure


value Options: 
g/L, g/dL, mmol/L

Cuvette symbol Checkmark


Visible:  Shows valid reading and
please insert cuvette passed self-check

Blinking:
please remove cuvette

Battery symbol Antenna pole


Shows battery charge status Shows RF connection
status and signal strength
Blinking:
(only with activated
Battery low
Bluetooth option)

Flash symbol
Visible:  USB symbol
Connected to power Shows USB connection status

Visible: 
Connected to host

Blinking:
Connected to host

7
DiaSpect Tm Operating Manual

5.5 Charging
The DiaSpect Tm analyzer has a built-in rechargeable battery.
The battery can be recharged by connection with the power supply or to a computer via a
USB cable. A USB cable and a power supply for charging the battery are supplied.

Charging by power supply:


1. Connect the USB cable with the analyzer
2. B  efore charging first time connect the adapter plug with the power supply
and leave connected.
3. Connect the USB cable with the power supply and plug the power supply
into a power outlet

1 2 3
Charging by power supply

Charging by computer:
1. Connect the USB cable with the analyzer
2. Connect the USB cable to the USB port of a computer.

1 2

Charging by computer

A battery symbol in the display shows the current charging state.


The flash symbol indicates that the instrument is connected to power.
Leaving the instrument connected to a power source when the battery is fully charged
will neither overcharge the battery nor decrease its lifespan.
A fully charged battery lasts up to 40 days / 10,000 tests of continuous use.
At the latest after 9 months the battery must be charged, even if not in use.

8
DiaSpect Tm Operating Manual

5.6 Data Transfer


The DiaSpect Tm analyzer comes with a USB 2.0 bus and Bluetooth interface.
For additional information, e.g. required software for data transfer, please contact the
manufacturer.

5.7 Cleaning
1. Pull the backside of the cuvette holder slightly towards you and lift up.
2. Clean the cuvette holder with cold water or a mild detergent, followed by
disinfectant.
3. Reinsert the dry cuvette holder by pressing down until you feel a “click”.
4. Clean device with cold water or mild detergent, followed by disinfectant

1 2 3 4

To disinfect the instrument, use conventional solvent-free surface disinfectants,


or alcohol based substances such as 70% isopropyl alcohol.

Do not spray the instrument when cleaning, as this will damage the
instrument!

Only use wipes lightly dampened in water/detergent/disinfectant for cleaning


and disinfection.

9
DiaSpect Tm Operating Manual

Surface Materials Used on DiaSpect Tm Analyzer

Analyzer surface Polycarbonate/Acrylonitrile Butadiene Styrene (PC-ABS)

Analyzer pane Polyether Sulfone (PES)

Analyzer feet Ethylene Propylene Dien Rubber (EPDM)

Cuvette holder Polycarbonate/Acrylonitrile Butadiene Styrene (PC-ABS)

USB cable Polyvinyl Chloride (PVC)

Adaptor plug Polycarbonate/Acrylonitrile Butadiene Styrene (PC-ABS)

Power supply Polycarbonate/Acrylonitrile Butadiene Styrene (PC-ABS)

5.8 Calibration and Control


The DiaSpect Tm analyzer is delivered factory-calibrated and requires no additional
calibration prior to operation.
The DiaSpect Tm analyzer will perform an automatic self-check after each measurement.
Passing the self-check verifies the measurement performance and is indicated by a
checkmark.
An error code is displayed if the self-check fails and the analyzer will cease measuring,
so there is no risk of an incorrect result being displayed.
DiaSpect Control HBT can be used for system control (analyzer, cuvette, sample
collection, and operator).
Follow all local, state and federal regulations, and other accreditation requirements.
Contact DiaSpect for additional information.

10
DiaSpect Tm Operating Manual

5.9 Disposal
Used cuvettes
Dispose of used cuvettes in a container for potentially infectious waste.
Consult local environmental authorities for adequate disposal.

DiaSpect Tm Analyzer
If you require DiaSpect Medical to dispose of the instrument and its components,
please return them to:

EKF-diagnostic GmbH
Ebendorfer Chaussee 3
39179 Barleben
Germany

Confirmation of appropriate disinfection of the instrument should be included in


the shipment.

For disposal by customer:


The lithium-ion battery in the DiaSpect Tm analyzer has to be disposed of separately.
For disposal of the battery, analyzer and power supply, follow the relevant regional or
local waste disposal regulations.

DiaSpect Control HBT


For disposal of the control material refer to the respective instructions for use.

11
DiaSpect Tm Operating Manual

5.10 Hazards
DiaSpect Tm Analyzer
Avoid strong mechanical shocks to the analyzer.

Do not expose the analyzer to liquids.

After storage or transport, allow the analyzer to acclimatize to operating temperature of


+10 °C to +35 °C (+50 °F to +95 °F) to prevent condensation damage.

Do not place the DiaSpect Tm analyzer in direct sunlight or near a heat source.

Do not place the DiaSpect Tm analyzer in, or next to, wet areas such as sinks or wash
basins.

Do not insert anything other than the USB cable into the socket in the back of the
analyzer.

Power supply
Only use the power supply provided with the instrument.

Do not expose the power supply to liquids.

Do not place the power supply near to heat sources or expose it to direct sunlight.

Do not use the power supply if its cable has a visible kink in it or becomes damaged.

Blood
Always handle blood as potentially infectious. Use gloves and avoid direct skin or mucous
membrane contact with donated blood, blood specimens, blood from filled cuvettes or
blood on the cuvette holder/DiaSpect Tm analyzer.

12
DiaSpect Tm Operating Manual

5.11 Service and Maintenance


The DiaSpect Tm analyzer does not require maintenance. For cleaning, see 5.7.

If damaged, the cuvette holder, USB cable, adaptor plug and the power supply can be
replaced by the user.

Should the DiaSpect Tm analyzer fail to function as intended, try to solve the issue by
using the troubleshooting guide, see 8. If this is not possible, return the DiaSpect Tm
analyzer to the manufacturer.

Never open the analyzer or the power supply.

Any repairs which may be necessary must be carried out by the manufacturer
or by authorized personnel only.

Failure to follow the specific operating instructions may result in warranty services offered
by the manufacturer being restricted.

For service and maintenance information, please contact:

EKF-diagnostic GmbH
Ebendorfer Chaussee 3
39179 Barleben
Germany

Phone:.................................................................. +49 (0) 39 203 511 414


Fax:.......................................................................... +49 (0) 39 203 511 171
Web:...............................................................www.ekfdiagnostics.com
Email:........................................................ support@ekf-diagnostic.de

13
DiaSpect Tm Operating Manual

6. Specimen Collection and Preparation for Analysis


Capillary, venous or arterial (EDTA or heparin anticoagulated) blood may be used.

6.1. Capillary sampling

Take a Diaspect Hemoglobin cuvette out of the foil bag and close the bag.

1. Make sure the hand is warm and relaxed. Use the middle or ring finger for sampling.
Avoid fingers with rings on.

2. Disinfect and dry the puncture site

3.G ently massage the finger towards the tip to increase blood flow.

4. Make the incision on the side of the finger tip. Use the ‘upward side’ of the finger
to facilitate filling of the cuvette.

1 2 3 4

5. A
 pply light pressure towards the fingertip until a blood drop appears.
Discard the first 3 drops and make sure there is a free blood flow before filling the
cuvette with the sample drop.

6. Be sure to have a sufficient sized blood drop to fill the cuvette.
Avoid contaminating the outside of the optical eye of the cuvette.
Fill the cavity of the microcuvette completely by touching the corner of the cuvette
to the blood drop. Do not refill the cavity of the microcuvette.

14
DiaSpect Tm Operating Manual

7. If a cuvette cannot be filled in one continuous process, or if the cuvette contains air
bubbles, discard the cuvette and use a new one. Wipe off excess blood outside of the
microcuvette with a dry tissue. Do not wipe the filling slit of the microcuvette!
This can draw the blood out from the cavity!

5 6 7

Repeated testing
Hemoglobin measurements from capillary samples may sometimes be misleading due to
sampling mistakes.

The most common causes for deviating results are choice of an unsuitable size or type
of lancet, incorrect capillary sampling technique, restricted capillary blood flow, or the
presence of extracellular fluid in the sample after pressing the fingertip too hard.

These factors commonly affect the result towards too low results. Confirmation of an
unexpected or unacceptable result can exclude potential pre-analytical factors as the
cause. As the DiaSpect method is very fast, this confirmatory test can preferably be done
using the same incision, as long as there is still a free flow of blood.

If the blood flow has stopped, another incision should be made for the confirming sample.
Record all results from repeated sampling, including relevant information about the
reason for re-testing.

15
DiaSpect Tm Operating Manual

6.2 Venous Sampling


If stored in a refrigerator*, the blood should be allowed to reach room
temperature before mixing.

Take a DiaSpect Hemoglobin Cuvette out of the foil bag and close the bag.

1. The blood must be well mixed prior to sampling. Mix by gentle inversion
at least 8 times.

2. Place a drop of blood on to a hydrophobic surface (e.g. Parafilm) using a


commercially available transfer pipette.

3. Avoid contaminating the outside of the optical eye of the cuvette. Fill the
cavity of the microcuvette completely by touching the corner of the cuvette
to the blood drop. Do not refill the cavity of the microcuvette.

If a cuvette cannot be filled in one continuous process, or if the cuvette


contains air bubbles, discard the cuvette and use a new one.

4. W
 ipe off excess blood outside of the microcuvette with a dry tissue.
Do not wipe the filling slit of the microcuvette! This can draw the blood out
from the cavity!

* We recommend venous or arterial blood to be analyzed within 72 hours

8x

1 2 3 4

16
DiaSpect Tm Operating Manual

6.3 Control Sampling

1. T
 he DiaSpect Tm system can be verified by use of DiaSpect Control HBT
Allow the control solution to reach room temperature first.
Mix the control solution by gentle inversion before sampling.
Open the vial and discard the first drop.
Take a Diaspect Hemoglobin cuvette out of the foil bag and close the bag.

2. Dispense a drop of the control solution on to a hydrophobic surface ( e.g. Parafilm)

Avoid contaminating the outside of the optical eye of the cuvette.


Fill the cavity of the microcuvette completely by touching the corner of the cuvette
to the drop. Do not refill the cavity of the microcuvette. If a cuvette cannot be filled
in one continuous process, or if the cuvette contains air bubbles, discard the cuvette
and use a new one.

3. W
 ipe off excess control solution outside of the microcuvette with a dry tissue.
Do not wipe the filling slit of the microcuvette!
This can draw the control solution out from the cavity!

1 2 3

17
DiaSpect Tm Operating Manual

7. Measuring

1. Insert the filled cuvette in the cuvette holder.

2. Press down gently until you feel a “click” and hold in position until you hear a beep.

3. T
 he hemoglobin value will be displayed instantly. Pull out the cuvette quickly. Dispose
of the used cuvette in a container for potentially infectious waste. Record the test result
as soon as the checkmark is shown.

4. The result will remain on the display until replaced by the next measurement. To erase
the latest result, simply make a “blank” measurement by pressing down the empty
cuvette holder.

1 2 3 4

Use only completely filled cuvettes for measuring. A filled cuvette should be analyzed
within 1 minute after filling. A filled cuvette should be kept in a horizontal position until
measurement. Do not re-measure a cuvette.

If the DiaSpect Tm analyzer has been out of use for a couple of hours, an error code
may appear after the first measurement. Remove the filled cuvette, make a “blank”
measurement by pressing down the empty cuvette holder and then reinsert the filled
cuvette for measurement.

18
DiaSpect Tm Operating Manual

8. Troubleshooting Guide

Symptom Possible cause Correction

Redo the sampling. Make sure


Unexpectedly high/ that the sampling is done in a
Improper sample
low result correct way. See 6.1 to 6.3 for
more information.

Contact the DiaSpect Tm


Error E01 Calibration lost
customer service department.

Repeat measurement with the


same cuvette. If ‘error’ persists,
Error E02 Sensor read error
contact the DiaSpect Tm
customer service department.

In order to reset the self-check


function, perform a “blank”
measurement*. E03 may be
Error E03 Self-check failed
displayed if a filled cuvette is
left in the cuvette holder, or was
removed too slowly.

Perform a “blank”
measurement*. If error persists
Error E04 Lightsource too dark
contact the DiaSpect Tm
customer service department.

Perform a “blank”
measurement*. If error persists
Error E05 Lightsource too bright
contact the DiaSpect Tm
customer service department.

Battery too low to perform


Error E07 Recharge the battery.
measurements

To recharge the battery,


connect with a power outlet or
Display blank, computer (see 5.5) and charge
measuring not Battery completely discharged for a minimum of 4 hours. If
possible recharging fails, contact the
DiaSpect Tm customer service
department.

* “blank” measurement: Press down the empty cuvette holder


(without cuvette inserted) until you feel a “click”.

19
DiaSpect Tm Operating Manual

9. Results and Reference ranges

The end of a measurement is signaled by a “beep”. The hemoglobin value will instantly
be displayed by the DiaSpect Tm analyzer. Record the result as soon as the checkmark is
displayed.

Different blood hemoglobin values have been reported in the literature.(4,5,6,7)

Adult Males 13.0-18.0 g/dL

Adult Females 11.0-16.0 g/dL

Children (2 yrs. to teenage) 11.0-16.0 g/dL

Infants (post-natal) 10.0-14.0 g/dL

Gradual increase from infant to adult levels.

The highest Hgb concentrations are usually measured in neonates.

Due to the wide range of conditions (dietary, geographical, smoking, exercise,


recumbency, etc.) which affect reference values(8), it is recommended each laboratory
establish its own expected ranges.

The hemoglobin value is displayed in g/dL by default. The result can also be displayed in
g/L or mmol/L.

Please contact the manufacturer if you require a change of the measuring units.

10. Performance Characteristics


The light path length through the cuvette cavity, in combination with the DiaSpect
hemoglobin analyzer, determines the exactness of the Hb measurement.

The DiaSpect Hemoglobin Cuvettes have a between lot imprecision of <0.1 g/dL
(< 1 g/L) hemoglobin.

20
DiaSpect Tm Operating Manual

11. Technical Specifications

Operating temperature +10 °C to +35 °C (+50 °F to +95 °F)

Operating humidity 0 to 100%, non-condensing

0 °C to +50 °C (-30 °C to +70 °C during transport,


Storage temperature
24 h max.)

Sample volume <10 μL

Measurement range 0–25.5 g/dL (0–255 g/L, 0–15.9 mmol/L)

Wavelength Multiple wavelengths ranges, 450 nm to 750 nm

Measuring time 1–2 s

Battery 3.6 V integrated lithium-ion rechargeable batteries

Safety Tested in accordance with IEC 60950 / IEC 61010

Instrument input rating 5 V, 100 mA (PC) / 350 mA (power supply)

Power supply input rating 4.5 VA, 100–240 V AC, 50–60 Hz

Data interface USB 2.0, Bluetooth Smart (optional)

Protection class IP 21

Max. 100 mA from USB host, max 350 mA from USB


Supply current
power supply

Several weeks for a fully charged battery and


Duration of use
continuous use

Analyzer dimensions L = 15 cm, W = 9 cm, H = 4 cm

Analyzer weight 180 g

Dimensions of transport box L = 23 cm, W = 16.5 cm, H = 7 cm

Weight of analyzer and transport box 570 g

The DiaSpect Tm analyzer complies with IEC 61326-2-6 for group 1, class B equipment
regarding electromagnetic compatibility, emission and interference immunity.

21
DiaSpect Tm Operating Manual

12. Limitations
The DiaSpect Tm analyzer is only to be used with DiaSpect Hemoglobin Cuvettes.

Neither the DiaSpect Hemoglobin Cuvettes nor the DiaSpect Tm analyzer may be used for
any purposes other than those specified.

Results deviating from the expected value should be confirmed with a laboratory
reference method.

WBC > 100x109/L (21-110x109/L), Triglycerides > 10 mM (3.0-11.1 mM), PLT > 750 x109/L
(598-794 x109/L), Microcytes < 80 fl (63-79 fl), Hb in Plasma > 10 g/L (1.0-11 g/L),
COHb > 7 % ( 2.2-7.2 %), Bilirubin > 50 μmol/L ( 57-357 μmol/L), low sO2 (Oxyhemoglobin)
< 50% (50-71%) have not been found to interfere (tested range in brackets).

A limited number of samples from individuals with sickle cell have been tested,
the results were not influenced.

The DiaSpect Tm analyzer and the DiaSpect Hemoglobin Cuvettes may only be used by
professionals.

13. References
1..NCLLS document H15-A3, Reference and Selected Procedures for the Quantitative Determination of
Hemoglobin in Blood; Approved Standard-Third Edition
2..Recommendations for reference method for haemoglobinometry in human blood (ICSH standard
1995) and specifications for international haemiglobincyanide standard (4th edition)
3. Dacie and Lewis, Practical Haematology, 11th edition, 2012
4..Fandek N, Moreau D, Newell K C, Ofner A, eds. Clinical Laboratory Tests - Values and Implications.
2nd ed. Springhouse: Springhouse Corporation, 1995: 328pp.
5. D
. eMott Wayne R, Tilzer Lowell L, Hematology. In: Jacobs DS, DeMott WR, Finley PR, Horvat RT,
Kasten Jr BL, Tilzer LL, eds. Laboratory Test Handbook. Hudson: Lexi-Comp, 1992: 517-626.
6..Wallach J. eds. Interpretation of Diagnostic Tests - A Synopsis of Laboratory Medicine, 4th ed.
Boston/Toronto: Little Brown and Co. 1986: 6pp.
7..Painter Pennell C, Cope June Y, Smith Jane L, Appendix. In: Burtis CA, Ashwood ER, eds. Tietz
Textbook of Clinical Chemistry. Philadelphia: WB Saunders, 1994: 2161-2217.
8..Tietz N, ed. Clinical Guide To Laboratory Tests, WB Saunders, 1983: 258-259.

Other:
− DiaSpect Hemoglobin Cuvette package insert
− DiaSpect Control HBT package Insert

22
DiaSpect Tm Operating Manual
The following accessories and spare parts may be used with the Diaspect Tm analyzer REF 90C.0100.

14. Accessories
DiaSpect Hemoglobin Cuvette REF 90C.0001
DiaSpect Control HBT1 REF 90B.0011
DiaSpect Control HBT2 REF 90B.0012
DiaSpect Control HBT3 REF 90B.0013
DiaSpect Control HBT4 REF 90B.0014
Carrying case for Diaspect Tm (plastic) REF 7049-8011-0179

15. Spare parts


Cuvette Holder REF 91B.0005
USB Cable REF 91C.0005
Power supply with adapter kit REF 91C.9010

23
DiaSpect Tm Operating Manual

16. Symbols Used

IP21 Protection of electrical equipment against foreign objects, water and


access

Instrument’s serial number

The CE mark documents the conformance of the DiaSpect Tm with the


essential requirements of the directive on in vitro diagnostic medical
devices

For in vitro diagnostic testing

Reference number

Dispose of the instrument in compliance with local regulations for the


disposal of electronic equipment. Do not put in domestic waste!

Read the supplied Operating Manual before starting

Attention, see the instructions for use

Manufacturer

Class II equipment

Biohazard

Direct current

24
DiaSpect Tm Notes

25
DiaSpect Tm Notes

26
DiaSpect Tm Notes

27
Sales
EKF-diagnostic GmbH
Ebendorfer Chaussee 3
39179 Barleben
Germany
Tel.: +49 (0) 39203 511 0

www.ekfdiagnostics.com

90C.0100B1 GB-01-20160730

You might also like

pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy