346105223-Swelab-Alfa-Manual-1504154-Apr-2006.en.fr

Contenu
PRÉFACE ....................................................................................................................................................... 3
introduction ............................................................................................................................................. 3
SECTION 1: SECURITE jeNSTRUCTIONS ....................................................................................................... 5

Aperçu de la section .................................................................................................................................. 5
1.1 Utilisation prévue ................................................................................................................................ 5
1.2 Consignes de sécurité ........................................................................................................................... 6
1.3 Biohazards ......................................................................................................................................... 6
Procédure d'urgence 1.4 ............................................................................................................................. 7
1.5 Les signes d'avertissement dans le manuel ................................................................................................ 7
1.6 Les signes de Équipement ..................................................................................................................... 8
SECTION 2: JeNSTALLATION ...................................................................................................................... dix

Aperçu de la section ................................................................................................................................ dix
2.1 Déballer ........................................................................................................................................... dix
2.2 Contraintes d'installation ..................................................................................................................... 11
2.3 Connexions électriques ....................................................................................................................... 12
2.4 Alimentation ..................................................................................................................................... 12
2,5 Connexion de l'imprimante .................................................................................................................. 13
2.6 Connexion, réactifs et changement Amorçage ......................................................................................... 14
SECTION 3: GENERALITES OPERÇU .......................................................................................................... 17

Aperçu de la section ................................................................................................................................ 17
3.1 Instrument Aperçu général .................................................................................................................. 17
Structure 3.2 Menu ................................................................................................................................. 18
3.3 débit.Système ................................................................................................................................... 20
3,4 volume de l'échantillon, le débit et les paramètres .................................................................................... 21
SECTION 4: INSTRUMENT Sise .................................................................................................................... 22

Sélection 4.1 Menu ................................................................................................................................. 22
4.2 Configuration initiale ......................................................................................................................... 23
4.3 Configuration avancée ........................................................................................................................ 24
4.4 Configuration réactif .......................................................................................................................... 27
Interface utilisateur 4.5 ............................................................................................................................ 28
SECTION 5: SAMPLE UNENALYSE............................................................................................................. 31

5.1 Préparatifs avant l'analyse ................................................................................................................... 31
5.2 Contexte Count ................................................................................................................................. 32
5.3 Exemple d'identification ..................................................................................................................... 33
5.4 Analyse de l'échantillon (tube ouvert) .................................................................................................... 34
5.5 Analyse de l'échantillon (procédure de pré-dilution) ................................................................................. 36
5.6 Analyse de l'échantillon (Micro capillaire d'entrée, MCI) .......................................................................... 38
5.7 Analyse de l'échantillon (Cap dispositif de perçage) ................................................................................. 40
5.8 L'analyse de l'échantillon (échantillonneur automatique) ........................................................................... 41
5.9 Résultats .......................................................................................................................................... 42
SECTION 6: QUALITÉ CONTRÔLE (QC) ET BLOOD CONTRÔLE MEMORY ............................................. 44

6.1 Contrôle de la qualité (QC).................................................................................................................. 44
6.2 Parcelles Levey-Jennings .................................................................................................................... 46
6.3 Initialisation et utilisation de la fonction XB ........................................................................................... 47
SECTION 7: CALIBRATION ......................................................................................................................... 49

7.1 Préparatifs avant l'étalonnage ............................................................................................................... 49
7.2 L'étalonnage ..................................................................................................................................... 50
1
SECTION 8: CPENCHÉ, MNTRETIEN & TRANSPORT ................................................................................ 53
8.1 Nettoyage quotidien ........................................................................................................................... 53
8.2 Nettoyage mensuel............................................................................................................................. 54
8.3 Six (6) Nettoyage du mois ................................................................................................................... 55
8.4 Entretien de l'instrument ..................................................................................................................... 56
8,5 Re-localisation d'instrument (au laboratoire) ........................................................................................... 56
8.6 Transport à court terme (<12H) ............................................................................................................ 57
8.7 Re-emballage et le transport à long terme (> 12H) ................................................................................... 57
8,8 arrêt et stockage permanent ................................................................................................................. 58
8.9 Informations sur l'élimination .............................................................................................................. 59
SECTION 9: PARAMETER FLAGS ................................................................................................................ 60

9.1 Brève description des drapeaux et dépannage ......................................................................................... 60
9.2 Description détaillée des drapeaux ........................................................................................................ 62
9.3 Capacités repérage des délinquants ....................................................................................................... 65
SECTION 10: TECHNOLOGIE ..................................................................................................................... 66

10.1 Principes de mesure .......................................................................................................................... 66
10.2 Le décompte RBC et WBC ................................................................................................................ 67
10.3 WBC Différentiels ........................................................................................................................... 68
SECTION 11: SPÉCIFICATIONS ................................................................................................................... 69

11.1 Généralités ..................................................................................................................................... 69
11.2 courte liste des spécifications ............................................................................................................. 70
11.3 plages de paramètres ........................................................................................................................ 71
11.4 Les réactifs et la consommation de réactif ............................................................................................ 71
SECTION 12: TÉPANNAGE ......................................................................................................................... 73

12.1 Problèmes de communication ............................................................................................................. 73
12.2 Affiche Informations générales ........................................................................................................... 74
12.3 Affiche d'avertissement ..................................................................................................................... 79
12.4 Questions Aspiration ........................................................................................................................ 83
12.5 Dépannage Autres questions .............................................................................................................. 83
jeNDEX ........................................................................................................................................................ 84
UNENNEXE UNE ..................................................................................................................................... 85
2
Préface
introduction
Swelab Alfa analyseur d'hématologie en 3 parties produites par Boule

Instrument médical à
la description application humaine.
Numéro de série Le numéro de série est situé à l'arrière de l'instrument.
Numéro de série
Figure 1.1
Une version de logiciel La version du logiciel est affichée lors du démarrage de l'instrument.
Une version de logiciel
Figure 1.2
3
Documentation Une documentation supplémentaire est disponible auprès de votre distributeur
supplémentaire agréé.
Documentation supplémentaire actuelle est ci-dessous:
 Service manuel
 Hématologie de base
 fiches produit
Spécifications Les exigences de l'opérateur suivantes doivent être remplies avant

de d'utiliser le système hématologique Swelab Alfa.
l'opérateur
 Les compétences de base dans un environnement de laboratoire.
 Les compétences de base en hématologie.
 Sensibilisation des IVD (UE) / exigences FDA (États-Unis) en ce
 qui concerne l'équipement de laboratoire.
 L'opérateur doit lire et comprendre ce manuel.
Accessoires en Accessoires et consommables listes sont disponibles auprès de votre

option et distributeur local.
consommables
Détails du Boule Medical AB

fabricant PO Box 42056
SE-126 13 Stockholm
Suède
Numéro de téléphone: +46 8 744 77 00

Numéro de fax: +46 8 744 77 20
Email: info@bm.boule.se
Distributeur
Les distributeurs sont inscrites à la cote http://www.boule.se
détails
Normes EN591: 2001

international IVD 98/79 / EG
es Ssen 61010-2-101 (basse tension 73/23 / EEC)
EN 61326 (1997) avec l'amendement EN 61326 / A1 (1998) (CEM 89/336
/ CEE) Normes harmonisées avec la FDA
Date d'Emission Avril 2006 Article n °: 1504154

4
Section 1: Consignes de sécurité
Aperçu de la section
Cette section décrit les caractéristiques de sécurité et les avertissements liés à

introduction la
Swelab Alfa.
Contenu Cette section aborde les sujets suivants:
Sujet voir la page

utilisation prévue 5
Consignes de sécurité 6
biorisques 6
Procédures d'urgence 7
Signes avant-coureurs dans le manuel 7
Les signes sur l'équipement 9
1.1 Utilisation prévue
Le Swelab Alfa est un analyseur d'hématologie automatique destiné à être in

La description vitro
tests de diagnostic des échantillons de sang dans des conditions de
laboratoire.
L'opérateur doit avoir des compétences de laboratoire de base et être au

Opérateur courant de bon laboratoire
Exigences entraine toi.
garantie  Le service doit être effectuée par Medical AB Boulé (ci-après dénommé
limites Boule) ou par le personnel de service autorisé par Boulé.
 Utilisez uniquement des pièces de rechange d'origine et réactifs, autorisé
Boulé contrôles sanguins,
calibrateurs et produits de nettoyage. (Si ces produits sont substitués, il peut
annuler
garantie)
 Les opérateurs et les superviseurs de laboratoire sont responsables que les
produits sont Boule
utilisé et entretenu conformément aux modes opératoires décrits dans les
manuels,
inserts de contrôle et des bulletins techniques.
Limitations  Chaque système est testé à l'aide Boulé réactifs recommandés, les
de garantie contrôles sanguins, calibreurs et produits de nettoyage. Toutes les
en demandes de performance sont générés dans le cadre de ce système
profondeur
 complet.
 produits Boule ne font pas des diagnostics sur les patients. Boule entend
ses produits de diagnostic (systèmes, logiciels et matériels) à utiliser pour
recueillir hématologique du patient. Ces données, conjointement avec d'autres
des données informations de diagnostic et l'évaluation de l'état du patient, peut être
reflétant utilisé par un clinicien formé pour établir le diagnostic d'un patient et de
l'état définir le traitement clinique.
5
1.2 Consignes de sécurité
La Boule intègre des fonctions de sécurité au sein de l'appareil afin de protéger

description l'opérateur contre les blessures, l'instrument contre les dommages et les
résultats des tests d'inexactitudes.
Afin d'assurer la sécurité de l'opérateur et l'instrument suivez les

restrictions instructions ci-dessous:
 Ne pas utiliser à l'extérieur de l'instrument.
 Ne modifiez pas l'instrument.
 Ne pas retirer le couvercle. (Personnel autorisé seulement)
 Ne pas utiliser l'instrument à d'autres fins que celles décrites dans ce manuel.
 Ne pas verser le sang ou d'autres liquides sur l'instrument de telle sorte
qu'il puisse fuir à travers le boîtier de l'appareil. (Cela pourrait entraîner
un mauvais fonctionnement électrique ou de blessure)


 Toute modification non autorisée de l'instrument pourrait entraîner
 des résultats erronés ou risque de choc électrique.
 fluides Renverser dans l'appareil pourrait causer un mauvais
Important fonctionnement électrique et / ou des blessures corporelles.


 Si un réactif entre en contact avec les yeux, rincer à l'eau courante
La
 pendant plusieurs minutes. En cas de symptômes consulter un médecin.
manipulati  Si le réactif entre en contact avec la peau, laver la zone affectée avec de l'eau.
on des  En cas d'ingestion, rincer la bouche. Si des symptômes persistants se
réactifs produisent consulter un médecin.
1.3 Biohazards
Comme il n'y a aucune garantie de l'absence du VIH, l'hépatite B ou C ou

La description virus
d'autres agents infectieux dans des échantillons sanguins, des contrôles
sanguins, les étalons et les déchets
ces produits doivent être manipulés comme potentiellement dangereux.
 Protection des travailleurs laboratoire à partir des maladies infectieuses

Soutien transmissibles par
infections acquises - 2 professionnellementDakota du Nord Édition, lignes
Documentation directrices approuvées
(2001) Le document M29-T2 promulgué par le Comité national pour
Normes de laboratoire cliniques aux Etats-Unis (NCCLS).
 Suivez la documentation réglementaire locale.
6
1.3 Biohazards (A continué)
Manipulation  Toujours porter des gants et des lunettes. Suivez les réglementations locales.
de matières  Manipuler des échantillons avec grand soin. Rapport d'incident
infectieuses
 conformément aux réglementations locales.
 Ne touchez pas le liquide des déchets lors de l'élimination des déchets.



 Si le sang entre en contact avec les yeux ou coupe ouverte, laver
 abondamment avec de l'eau.
action obligatoire
 Si le liquide des déchets est par inadvertance touché, laver la zone
affectée avec une solution désinfectante d'abord et suivre avec du
savon.
Procédure d'urgence 1.4
En cas de S'il y a des signes évidents de dysfonctionnement tels que des fuites de
urgence fumée ou de liquide hors de l'appareil, procédez comme suit:
Étape action
1 Débranchez l'alimentation principale immédiatement en tirant le
cordon de l'alimentation principale.
2 Contactez votre distributeur agréé.
1.5 Les signes d'avertissement dans le manuel
Panneaux de signalisation Les signes d'avertissement suivants dans le manuel sont utilisés
pour identifier les dangers possibles et de faire appel à l'attention de
l'opérateur à cette condition.
Une
Signe fonction
Indique les procédures de fonctionnement qui

pourraient entraîner des blessures ou des
pertes de vie si pas suivi correctement.
Attention
Indique les procédures de fonctionnement qui

pourraient causer des dommages ou la
destruction du matériel en cas pas strictement
observée.
Mise en garde
Insiste procédures de fonctionnement qui

doivent être suivies afin d'éviter des résultats
erronés.
Important
Indique que les vêtements de protection, des
gants ou gog-gles doivent être utilisés lors de
l'exécution des procédures décrites.
action obligatoire
7
1.6 Les signes de Équipement
La description Les signes placés sur l'instrument définissent des zones qui nécessitent une
attention particulière ou des zones qui contiennent danger. Voir IVD Table
des symboles à la page 9.
Les signes sur l'équipement
Figure 1.3 Figure 1.4
8
Figure 1.7 IVD Symbole Tableau
9
Section 2: Installation
introduction Cette section décrit comment déballer et installer l'instrument Swelab Alfa.
Assujettir Sujet
Déballage dix
Contraintes d'installation 11
Connections electriques 12
Source de courant 12
Connexion de l'imprimante 13
Connexion, Changement et réactifs Amorçage 14
2.1 Déballer
La description L'appareil est emballé dans une boîte de protection spécialement conçu.
Contrôle visuel Cochez la case pour les dommages matériels. Si immédiatement

endommagé, informez votre transporteur.
Inclus  Instrument
Matériel  Manuel d'utilisation
 Tube de déchets
 Capteur de niveau de réactif et de bouchons de réactifs pour diluant
isotonique (Diluant)
 Capteur de niveau réactif et bouchons de réactifs pour réactif hémolyse (Lyse)
 Cordon d'alimentation
 Formulaire d'installation
 Lecteur externe code-barres
Optionnel  Imprimante
Matériel  Papier d'imprimante
 kit MCI
 Clavier externe
 Réactifs, contrôles sanguins, calibreurs et produits de nettoyage
dix
2.2 Contraintes d'installation
Les procédures suivantes doivent être suivies à la lettre. Boule

n'a aucune responsabilité en cas d'une installation défectueuse
Important
ou erronée.
Installation
/ Placement L'instrument doit être placé dans un environnement de laboratoire selon les
d'exploitatio directives ci-dessous:
n  Placez l'instrument sur une surface horizontale propre.
 Évitez l'exposition au soleil.
 Assurez-vous que l'appareil dispose d'un accès à une bonne ventilation.
 L'instrument doit avoir au moins 5 cm (2 pouces) de l'air au-dessus.
 Placer l'arrière de l'instrument de sorte qu'il a au moins 10 cm (4
pouces) d'espace libre derrière elle.
5 cm
10 cm
Figure 2.1
Installation /  utilisation à l'intérieur

Environneme  Température 18 à 32 ° C (64 à 90 ° F)
nt  Humidité <80% relative
d'exploitation
 alimentation principale Grounded
Utilisation de l'instrument dans un environnement au-dessus de 32 ° C

(90 ° F) augmente les besoins de service, ainsi que la dégradation de
Important
l'échantillon de l'échantillon.
11
2.3 Connexions électriques
La description Toutes les connexions sont situées sur le panneau arrière de

l'appareil. Les connexions sont disponibles comme indiqué ci-
dessous:
1
2
3
4
7
6
Figure 2.2
Nombre Partie Une fonction

1 Port d'imprimante Relie l'imprimante à l'analyseur
2 Port clavier Relie clavier externe à l'analyseur.
3 Port série (mâle) Relie l'ordinateur à l'analyseur.
4 Port série (femelle) Connecte Barcode Reader à l'analyseur.
Relie la sortie de l'alimentation principale à
5 Port d'alimentation l'analyseur.
Connecteur de masse se connecte à
6 connecteur sol l'analyseur.
Capteurs Relie réactif Capteurs de niveau à
7 électroniques l'analyseur.
2.4 Alimentation
environneme L'alimentation principale est située en interne et conçu pour être utilisé
nt principal à l'intérieur. L'alimentation est sans danger pour la tension transitoire
d'alimentati telle que définie dans la norme CEI 801-4.
on
Risque de choc électrique.

 L'instrument ne doit être raccordé à une alimentation secteur à la terre.
Cela pourrait entraîner violer des blessures et / ou la perte de la vie et /
ou les résultats des paramètres erronés.
Attentio
n
Suite à la page suivante
12
2.4 Alimentation (A continué)
Manipulation de Si les transitoires à haute tension sont attendus sur l'alimentation

haute tension principale, s'il vous plaît suivre les recommandations ci-dessous.
transitoire
Risque de choc électrique.

 Installation d'équipement électrique externe tel que CVT ne doit être
effectuée par des techniciens autorisés. Cela pourrait entraîner violer
des blessures et / ou la perte de la vie et / ou les résultats des paramètres
Attention
erronés.
En cas de Symptôme Solution

Une CVT (stabilisateur
haut transitoire compte de fond -Haute magnétique)
tension au- devrait être mis en œuvre pour
dessus sur RBC, PLT ou WBC. maintenir la
15% instrument -Defective. instrument d'être endommagé.
(En général, éviter l'utilisation d'un
UPS.)
Des lignes Les directives sont données dans le manuel d'entretien «dispositifs auxiliaires
directrices d'installation »
section. Contactez votre distributeur agréé dans un tel cas.
Dans le cas d'une perte de puissance soudaine il n'y aura pas de dommages
Puissance causés à la
instrument. constantes d'étalonnage et d'autres paramètres nécessaires à
interruptions l'exploitation
sont protégés contre la perte principale
d'approvisionnement.
Avant Pour exécuter l'instrument, la fréquence et de la tension principale doit

correspondent à la prise d'alimentation de
de liaison l'utilisateur.
 Localiser la plaque de numéro de série à l'arrière de l'analyseur et
vérifier que la tension principale et la fréquence correspond à la sortie
 principale locale.
 Si la tension et / ou la fréquence ne correspond pas, contactez
votre distributeur agréé
De liaison Insérez le câble d'alimentation dans l'entrée principale d'alimentation de

l'appareil et connectez-vous au
Câble d'alimentation
alimentation principale. (Cette opération ne doit être
effectuée après le raccordement des récipients de réactif).
2,5 Connexion de l'imprimante
La description L'imprimante est connectée à l'arrière de l'appareil avec le câble d'imprimante.

(Imprimante n'est pas fabriqué par Boulé.) Voir la figure 2.2 pour plus de détails.
13
2,5 Connexion de l'imprimante (A continué)
Prise en charge DPU 411/2 et 414 DPU (fourni par un accessoire Boule en option).
Suivez les instructions dans le manuel de l'utilisateur de l'imprimante à
imprimantes installer.
Compatible HP-PCL, IBM Proprinter

Si vous utilisez une de ces imprimantes voir la section 4.3 pour les
imprimantes instructions d'installation.
2.6 Connexion, réactifs et changement Amorçage
La Les réactifs pour l'instrument sont livrés dans des boîtes de cube
description formés avec des bouchons en plastique.
réactif hémolytique et isotonique Diluent, ci-après dénommé Lyse et le

Prise en diluant. (Spécifiquement conçu par Boule pour le système Swelab Alfa).
charge
réactifs
Cette section décrit le placement des conteneurs de réactifs.
 Il est recommandé que les deux Diluant et les réactifs Lyse sont placés au
Location de  niveau de l'instrument ou au-dessous.
Réactif  Mise en place des conteneurs de réactifs au-dessus du niveau de
l'instrument pourrait causer problème de débit du système et n'est
Remarque pas recommandé.
réactif de liaison Cette section décrit comment connecter les conteneurs de réactifs pour
conteneurs
une utilisation.
Étap
e Relier
1 Le capteur de niveau de réactif Lyse (jaune) et le capteur électronique à
l'analyseur.
2 Le capteur de niveau de diluant (rouge) et le capteur électronique à
l'analyseur.
Figure 2.3
14
2.6 Connexion, réactifs et changement Amorçage (A continué)
Étape Insérer
Les capteurs de niveau de réactif dans les récipients de réactif
3 correspondant.
Figure 2.4
Déchets Connecter le tube d'échappement (noir) à l'analyseur. Placer l'autre

extrémité du tube de déchets directement dans le système de drainage ou
dans un conteneur de déchets, suivant la réglementation locale. Voir la
section 8.9 pour obtenir des informations d'élimination.
L'extrémité du tuyau d'évacuation doit être à un niveau plus bas que

Mise en
l'instrument lui-même. Ne pas suivre cela peut conduire à des fonctions
garde inappropriées d'instruments et / ou des déchets liquides refluer dans
l'appareil.
Toujours utiliser des gants de protection lorsque vous travaillez avec le

action obligatoire
conteneur de déchets et le tube de déchets.
système de
remplissage
 Pour le remplissage initial de l'analyseur, branchez l'analyseur et activer /
 désactiver l'interrupteur sur ON.
 Appuyez sur la touche [EXIT] lors de l'affichage de l'invite de
remplissage, et suivez les instructions ci-dessous pour remplir l'analyseur.

15
2.6 Connexion, réactifs et changement Amorçage (A continué)
Étap
e action
Sélectionnez l'onglet
1 MENU.
2 Appuyez sur [REACTIFS SETUP] puis appuyez sur [ENTRER LE
REACTIFS].
Numériser des codes-barres sur les conteneurs de réactifs, lorsque tous
3 les codes-barres sont entrées
un écran affiche les codes-barres que réactifs ont été acceptés.

4 Retour au menu principal du menu et appuyez sur [ADVANCED].
5 Appuyez sur [ENTRETIEN], puis [SYSTÈME FILL].
Figure 2.7 Figure 2.8 Figure 2.9

6 Le système remplit maintenant avec des réactifs. Ce cycle va
Amorçage durer pendant environ 3 minutes.
Exécution Après l'exécution d'un cycle de remplissage, il est recommandé d'exécuter un

d'un cycle cycle d'amorçage.
de premier
Pour exécuter un cycle premier onglet, sélectionnez MENU puis appuyez sur
[SYSTEM PRIME].
16
Section 3: Présentation générale
introduction Cette section contient des informations générales sur l'instrument et en option
accessoires.
Sujet voir la page

Instrumentation générale Vue d'ensemble 17
Menu Système 18
débit.Système 20
Volume de l'échantillon, le débit et les paramètres 21
3.1 Instrument Aperçu général

9
instrument
Vue
d'ensemble
7
6
4
2 3 8
Figure 3.1
Partie Une fonction
LCD à écran tactile, monochrome ou couleur, avec incorporé
1. Afficher clavier et pavé numérique.
2. Le total aiguille artérielle Aspirats sang total.
aiguille / distributeur de Aspirats échantillons pré-dilués en rendant superflue
3. pré-dilué diluant.
Micro capillaire d'entrée permet à l'utilisateur d'analyser 20 ul de
4. MCI (facultatif) sang.
Imprime les exemples de résultats. (Non représenté, le modèle
5. Imprimante (en option) dépend utilisateur)
lecteur de code à barres permet à l'utilisateur d'entrer rapidement
le patient, le contrôle et
6. code à barre identifications de paquets de réactifs, et utilisent le
programme QC.
7. Mixer (facultatif) mélanges d'échantillons de façon uniforme.
8. Échantillonneur (facultatif) Permet échantillons consécutifs à analyser
automatiquement.
Analyse des échantillons avec diminution du risque de
9. Cap Piercer (en option) contact avec le sang.
17
Structure 3.2 Menu
3.1 Menu principal ordinogramme Structure
Select Analysis Profile

11 possibilities of Analysis profiles
nouvel Next
Menu principal échantillon Prev
nouvel échantillon > ID _______
Ok
Échantillon > 1,2,3..CE ..
liste > profil Exploitations > Run Con/Cal Blood
profil suivant
Menu profil prev
12 possibilities of Control blood
Premier definitions Next
Run Con / Cal >
Prev
Dispenser Échantill
Éteindre onneur (Le cas échéant)> Cancel
Etre prêt A, B, C .. 1 (3) >
Avancée > D'accor
d ¤ Auto Sampler List
Q/C > Pos St. SEQ ID
Configuration du réactif Annuler < 1-20
>
Start
ExtraMix
Échantillon Pause
nouvel Stop
échantillon > Exit
[GRAPH WBC]
[GRAPH RBC]
1/3 ABC
[GRAPH PLT]
2/3 abc
[RESULTAT
3/3 123...!?/...CE
PARAMETER]
! Ok
Précéd Cancel
ent ¤
Suivan
t ¤
1 (3) >
liste Select Sample Criteria
Menu < ID __________________
Impres Seq(fr-to) ____________
sion Date (fr-to)____________
Profile
Today
Select All
Selected __/__
liste Exit
nouvel
Delete
échantillon >
Échanti Send
llon Stats
Change >
[SEQ. x-y LISTED]
Previous ¤
Next ¤
1(6) (param. listed) >
Menu <
Q/C Menu
View Con/Cal >
View Xb Stats >
Enter Con/Cal > Reagent Barcode Input
View Assays >
Exit >
Exit <
View Reagent Statistics

Reagent Setup Menu Current Lyse/Diluent
Enter New Reagent > Cycles Left
View Reagents > Lot No./Pack No.
Exp. Date
Inactivate Reagent > Open Date/Last Date
Print
Exit
Inactivate Reagent
Yes >
No >
18
3.2 Menu System (Continued)
Flowchart 3.2 Advanced Menu Structure
Calibration
Whole Blood >
Predilute >
Capillary Device >
Closed Tube Device >
Calibration Log >
Exit <
Maintenance
Prime System
Clean Orifice
Fill System ¤
Clean Cycle >
Empty System
Clot Prevention ¤
Exit <
Service Menu 2
Service Menu Serial no
Serial no Firmware
Firmware Blood Detector >
Clot Removal > Level Detectors >
Noise test > Beaker Detector >
PTest > Reagent Detector >
Advanced Pump & Valve > HGB >
Calibration > Instrument Log > Shear Valve >
Maintenance > Service Setup 2 > Needle (if applicable) >
Service > Exit < Exit <
Setup >
Exit <
Setup Menu 1 Setup Menu 2 Setup Menu 3

Print Setup > Barcode Setup > Color setup >
Serial Setup > Memory Setup > Mixer Setup >
Print All Settings > Blood Det. Setup > Deley Predilute >
Send All Settings > Standby Setup > PLT offset Setup >
SEQ No. Setup > Date/Time Setup > High Alt. Setup >
Setup Menu 2 > Regional Setup > Xb Range Setup >
Analysis Profile > Setup Menu 3 > Instrument ID >
Exit < Exit < Exit <
Analysis Profile Setup

Activate
[X] >
Default >
Name >
Block parameters >
Normal Ranges >
WBC setup >
RBC/PLT Setup >
Misc. Setup >
Next / Prev
Exit <
19
3.3 System Flow
Description This section contains the system flow concerning standby and cleaning cycles.
Flowchart 3.3 System Flow
After 15 minutes*
Screen Saver
Mode**
After 2 hours* Before 2 hours*
In Standby Press anywhere on

Mode screen to view screen
Press anywhere on
screen to view screen Press [EXIT]
Press [EXIT] to exit

standby mode*** Returns user to
last displayed page
* This time amount is user adjustable.
** Possible to start directly if in View Sample,

List Sample, or Main Menu screens.
*** Default automatically runs background count.

If default is inactivated by user, background
count run recommended.
20
3.4 Sample Volume, Throughput, and Parameters
Description The Swelab Alfa is a fully automated cell counter reporting up to

20 parameters.
Sample volume < 90 µl
Throughput > 67 (open tube, whole blood) samples per hour.
20 Parameters See list of parameters below:
Leukocyte parameters 20 16 10
WBC Total White Blood Cell Count Yes Yes Yes
LYM% Lymphocytes percentage Yes Yes No
LYM# Lymphocytes (absolute) Yes Yes No
MID% Mid Cell Population percentage Yes Yes No
MID# Mid Cell Population (absolute) Yes Yes No
GRAN% Granulocytes percentage Yes Yes No
GRAN# Granulocytes (absolute) Yes Yes No
Erythrocyte parameters 20 16 10
RBC Total Red Blood Cell Count Yes Yes Yes
HGB Hemoglobin Concentration Yes Yes Yes
HCT Hematocrit Yes Yes Yes
MCV Mean Cell Volume of RBCs Yes Yes Yes
MCH Mean Cell Hemoglobin Yes Yes Yes
Mean Cell Hemoglobin
MCHC Concentration Yes Yes Yes
Red Blood Cells distribution
RDW% width percentage Yes Yes Yes
Red Blood Cells distribution
RDWa width (absolute) Yes No No
Thrombocyte parameters 20 16 10
PLT Total Platelet Count Yes Yes Yes
MPV Mean Platelet Volume Yes Yes Yes
PDW Platelet Distribution Width Yes No No
PCT Platelet Crit Yes No No
Large Platelet Concentration
LPCR Ratio Yes No No
21
Section 4: Instrument Setup
Section Overview
Introduction This section covers the initial configuration needed to customize the
instrument settings.
Contents This section contains the following topics:
Topic See Page

Menu Selection 22
Initial Setup 23
Advanced Setup 24
Reagent Setup 27
User Interface 28
4.1 Menu Selection
 The List Menu will be displayed upon initialization.

Main Menu upon
initialization  From this main screen all other menus can be accessed for setup.
 By selecting the MENU tab and then pressing [ADVANCED]
the Advanced Menus will be displayed.
List and
System Menu
22
4.2 Initial Setup
Setting up
Change of display language is performed by following the instructions below:
language
Step Action
1 Start by pressing [ADVANCED] from the MENU tab.
2 Press [SETUP].
3 Press [SETUP MENU 2].
4 Press [REGIONAL SETUP], a list of local settings will be displayed.
5 Press [MORE] until language button is displayed.
6 Press [LANGUAGE] to enter language screen.
7 Choose the number that corresponds with the language desired
and press OK to save.
Menu
Activate Mixer
To activate mixer follow the instruction below:
(optional)
Step Action
2 Press [SETUP] and then [SETUP MENU 2].
4 Press [MIXER].
If the mixer is not activated the button will have empty
5 brackets ( [ ] ). To activate press button and select [X].
Upon sample aspiration mixer will discontinue rotation
Note until sample analysis is complete.
It is recommended that whole blood samples are mixed for
10 – 15 minutes and then analyzed. Mixing for more than
4 hours may cause erroneous results.
Important
Continued on next page
23
4.2 Initial Setup (Continued)
Setting up The date/time function is shown on all samples and printouts and should
date/time always be setup correctly. To set date/time follow the instruction below:
Step Action
2 Press [SETUP], then press [SETUP MENU 2].
3 Press [DATE/TIME SETUP] to enter the set date/time menu.
4 Press [DATE FORMAT] to select date specific setting.
1 = DD/MM/YY; 2 = YY/MM/DD, 3 = YY/DD/MM, 4 = MM/DD/YY
5 Press on the item that you want to change and enter the changes on the
numerical pad. See menus below.
Menus
4.3 Advanced Setup
Description This section describes how to install and configure external components
such as barcode readers, printers, data communication, etc.
Select Follow the instruction below for interfacing analyzer to printer.

Printer Type (To connect printer see Section 2.5)
Step Action
2 Press [SETUP] and then [PRINT SETUP] to enter the Print Setup
menu.
3 Press [MORE] to view Printer type. Printer types are as follows:
1 = Seiko DPU 411/12 and 414
2 = IBM proprinter / Epson compatible
3 = HP PCL 3 and 5 protocol compatible
4 To change printer type press [PRINTER TYPE], enter the
correct number and press [OK] to save.
24
4.3 Advanced Setup (Continued)
Print modes To select options for printing results.
Step Action
2 Press [SETUP].
3 Press [PRINT SETUP] to enter the printer setup menu.
4 To set Manual Print Mode function select from the following:
0 = None, 1 = Without Histograms, or 2 = With Histograms.
5 To select Auto Print Mode function select from the following:
Note Extended printer format settings and user definable print layouts
are also available. Please refer to Document 02012.
(www.Swelab.se/support/html/whatsnew.htm), for detailed
information on how to set up a user definable format.
Requirements: English language only. Requires basic
understanding of printer protocol, formats and font definitions.
Barcode Setup To setup the barcode reader follow the instructions below. (Note that
the default barcode setting is 9600N81).
Step Action
2 Press [SETUP].
4 Press [BARCODE SETUP] to enter the barcode setup menu.
5 Choose the format that is appropriate for the barcode reader being
installed. (The generic driver is most common and is Compatible
with most readers).
0 No barcode reader
1 Generic barcode reader (9600N81)
2 Panasonic ZE-84RMSM (9600O72)
Note An Internal barcode reader is also available on some models. To

activate follow Steps 1-4 and select [X] button.
Keyboard To setup the keyboard follow manufacturer instruction for setup and plug
Setup (optional) into analyzer keyboard port. See Section 2.3 for details.
25
4.3 Advanced Setup (Continued)
Data The instrument is equipped with an output for connection to a

Communication computer (network). The serial output has a male 9 pin DSUB. It
fulfills the RS232 specification.
The pinning of the male 9-PIN-DSUB is as follows: (instrument end)

1 Not used
2 TX-OUTPUT
3 RX-INPUT
4 Not used
5 GND
6 Not used
7 CTS-INPUT
8 RTS-OUTPUT
9 Not Used
To connect to a PC computer that uses a 25 pin RS232 (Female -> Female)

see instructions below:
Cable end instrument (9 pin) Cable end PC (25 pin)

2 3
3 2
5 7
7 4
8 5
Connections to a pc using a 9pin RS232
Cable end instrument (9pin) Cable end pc (9pin)
2 2
3 3
5 5
7 7
8 8
To select options for sending results and data follow instruction below:
2 Press [SETUP].
3 Press [SERIAL SETUP] to enter the serial setup menu.
4 To set Manual Send Mode function select from the following:
5 To select Auto Send Mode function select from the following:
26
4.4 Reagent Setup
Description This section describes the functions of the reagent setup menu and how
to access reagent statistics.
Reagent Input The Swelab Alfa System is interlocked with specified Boule reagents for
(Enter New optimal performance. The reagent containers must be identified by the
Reagents) instrument before analysis of samples can begin. To identify reagents scan in
or manually enter the barcodes on the reagent containers. See section 2.6.
View Reagent Reagent statistics can be viewed in two ways:
Step Action
1 Start by pressing [REAGENT SETUP] from the MENU tab.
2 On the lower left-hand side of the Reagent Setup Menu, both the
remaining cycles for Diluent and Lyse are displayed. (It is important to
remember that cycles include analyses, wash cycles, background
counts, primes, exit standbys, etc.)
3

4 The second method of viewing reagent statistics is by pressing [VIEW
REAGENTS] from the Reagent Setup Menu. This screen is divided
into the last four Lyse Reagent Statistics and the last four Diluent
Reagent Statistics. For each, the operator can view the following:
 [X] indicates which reagent is currently activated.
 The number of cycles left for specific reagent container.
 The Lot and Pack Numbers
 The expiration date of the specific reagent container.
 The Open Date, when the reagent container was first used on
the system.
 The Last Date, when the last time that reagent container was
used to run a cycle.
27
4.4 Reagent Setup (Continued)
Inactivate It is possible for the operator to inactivate the current reagent box by pressing
Reagent the [INACTIVATE REAGENT] button and then [YES]. Once deactivated the
operator must scan in or manually enter another reagent container before
analysis of samples can begin.
Reagent The interlocked reagent system displays indicator and warning messages to
Indicators alert the operator when reagents are running low and need to be changed. See
Section 12.2 and 12.3.
4.5 User Interface
Description This section describes the functions of available menus in the instrument that
have not been described in any other section of this manual.
Analysis Profile It shall be possible for operators to customize analysis profiles. See following
menu options:
Step Action
2 Press [SETUP], then [ANALYSIS PROFILE] to enter the Analysis
Profile Setup menu.
3

4 To set profile name press [NAME].
 Press [PREV] or [NEXT] to choose an open profile on list.
 Press [NAME ON DISPLAY] to enter new profile name and press
OK when complete.
 Press [NAME ON PRINTOUT] to enter new profile name to be
displayed on printout and press OK when complete.
5 To set new profile as default press [DEFAULT] and select [X].
28
4.5 User Interface (Continued)
6 To block certain parameters press [BLOCK PARAMETERS] to see

list and then [MORE] to view specific parameters. Press any
parameter and select [X] to block parameter.
7 To change RBC/PLT discriminators press [RBC/PLT SETUP] to
see list and then [MORE] to view specific discriminators. Press
specific discriminator button to change value and then OK to save.
8 To change WBC discriminators press [WBC SETUP] to see list
and then [MORE] to view specific discriminators. Press specific
discriminator button to change value and then OK to save.
9 To change normal ranges press [NORMAL RANGES] to see list
and then [MORE] to view specific parameter range. Press specific
parameter range button to change value and then OK to save.
10 New profiles are automatically included in XB functions and Stats. To
not include new profile in Xb functions or Stats press [MISC SETUP]
and change [X] to ([ ]), respectively to inactivate default setting.
Sample Memory The following procedures explain how to search for previous sample analyses
and statistics, and print, send, and delete samples.
Step Action
1 To view previous analyses at a quick glance press [PREV] or [NEXT]
buttons to scroll through samples in either Sample or List menus.
2 To view a specific sample or a group of samples press [CHANGE] in
List Menu. In this menu samples can be selected by Sample ID,
SEQ, Date, and Sample profile. Press corresponding button to select.

3 To view Sample Statistics, select sample or group of samples to view,
and press [STATS] to enter the Statistical Results menu.
4 To print or send selected sample or sample statistics press [PRINT] or
[SEND].
5 To delete selected sample or group of samples press [DELETE]. The
instrument will display a prompt to verify deletions, press [YES].
29
4.5 User Interface (Continued)
All Settings From Menu tab press [ADVANCED] and then [SETUP] to enter Setup Menu.
 To print all instrument settings, verify instrument is connected to a
 printer and press [PRINT ALL SETTINGS].
 To send all instrument settings, verify instrument is connected to a
computer and press [SEND ALL SETTINGS].
Change From Menu tab press [ADVANCED] and then [SETUP] to enter Setup Menu.
Sequence To change sequence number press [SEQ NUMBER SETUP], press [NEXT
Number SEQ NUMBER], enter in new sequence number and press OK to save.
Platelet Contact local distributor for more information on Platelet Concentrate Mode
Concentrate activation.
Mode
30
Section 5: Sample Analysis
Section Overview
Introduction This section covers the sample analysis routine, including how to analyze a
sample in the five different modes offered in the Swelab Alfa.
Topic See Page

Preparations before Analysis 31
Background Count 32
Sample Identification 33
Analyzing the Sample (Open Tube) 34
Analyzing the Sample (Pre-dilution procedure) 35
Analyzing the Sample (Micro Capillary Inlet, MCI) 37
Analyzing the Sample (Cap Piercing Device) 39
Analyzing the Sample (Auto Sampler) 40
Results 42
5.1 Preparations before Analysis
Sample Human venous blood samples should be collected in an EDTA K3 or EDTA

collection K2 tube in sufficient quantity and be gently mixed immediately after sampling
in order to obtain accurate results. Please follow the recommendation of the
EDTA tube supplier.
Limitations Samples drawn in an open tube or vacuum tube should be analyzed between
15 minutes and 6 hours for most accurate results.
Anticoagulant EDTA K3 (Ethylene Diamine Tetracetic Acid, Tri-potassium) liquid and

recommendation EDTA K2 (Ethylene Diamine Tetracetic Acid, Di-potassium) spray-dried
solution. Recommended by ICSH and NCCLS.
Handling of  The blood should be allowed to adapt to the EDTA for 10-15 minutes after
samples sampling.
 The sample should be thoroughly and gently mixed before analysis. It is
recommended to use a mixer.
 The sample should be mixed for 10-15 minutes. A sample not correctly
handled may give erroneous results.
31
5.1 Preparations before Analysis (Continued)
The sample should be kept at room temperature. Excessive cold or heat

could cause erroneous results.
Important
 As there are no assurances of the absence of HIV, Hepatitis B or C viruses

or other infectious agents in blood samples, blood controls, calibrators and
Warning  waste these products should be handled as potentially biohazardous.
 Always wear protective gloves and goggles. Follow local regulations.
5.2 Background Count
Background The following sequence is performed to check that the background count
Check is low enough to run a sample.
Step Action
1 From the main screen press [NEW SAMPLE].
2 Press [NEXT PROFILE] or [PREV PROFILE] to scroll
to Background and press OK to save.
3 Press the whole blood start plate, which is located behind
whole blood aspiration needle. (See Figure 5.1 below)
Figure 5.1
The aspiration time is approximately 10 seconds. After ~ 10
seconds the instrument will time out due to no detection of
blood, and continue its cycle.
Accepted
The background count should not be higher than the figures shown
Background
values below, assuming that at least 2 “blanks” are run after a sample.
Parameters Values accepted

RBC ≤ 0.01 (1012/ L)
WBC ≤ 0.1 (109/ L)
HGB ≤ 0.2 (g/ dL)
PLT ≤ 10 (109/ L)
32
5.3 Sample Identification
Description This section describes the different methods of inputting Sample

IDs (Identification).
ID Input The ID can be entered with the following methods:

Methods  Manually (touch screen or external keyboard)
 Barcode


Character Input

 15 Characters
Limitations
Step Action
1 From the main screen press [NEW SAMPLE] or begin sample
aspiration, which automatically opens NEW SAMPLE menu.
2 Press numerical keys to enter sample ID or scan in the ID barcode
from the sample tube.
3 Press [NEXT PROFILE] or [PREV PROFILE] to scroll to desired
profile.
4 Press OK to save profile and sample ID or begin sample aspiration.
Menu

5 Aspirate sample following selected procedures in sections 5.4 – 5.8.
Note Sample ID entry and profile selection can be preformed up to 30
seconds after sample aspiration.
33
5.4 Analyzing the Sample (Open Tube)
Description This section describes how to aspirate and analyze a sample with the “Open
Tube” procedure.
Starting Refer to Section 5.1 for blood sample preparation and then follow the
procedure procedure below:
Step Action
Choose List, Sample, or Main menu to begin sample analysis.
1 Analyzer must be in one of these operation modes to aspirate.
Aspirate the sample through the aspiration needle by gently inserting
2 aspiration needle into the sample tube, press the whole blood start
plate behind the left aspiration needle. (See Figure 5.4)
Follow the instruction on the menu when to remove the sample tube.
3 A beep should be heard indicating sample removal.
 Make sure that the blood sample tube is not touching the upper part of the
aspiration needle.
 Not removing the sample tube could result in incorrect washing sequence
of the aspiration needle.
Important  Do not remove sample prior to instruction, incomplete aspiration could
occur, causing erroneous results.
Sample Aspiration
4
Figure 5.4
 As there are no assurances of the absence of HIV, Hepatitis B or C viruses
or other infectious agents in blood samples, controls, and calibrators these
products should be handled as potentially biohazardous.
Warning
 Always wear protective gloves and goggles. Follow local regulations.
34
5.4 Analyzing the Sample (Open Tube) (Continued)
Sample Aspiration Display

5

The instrument now switches to the Sample analysis screen.
6

7 In first screen displayed above Sample ID and profile can still
be added. If any buttons are pressed in this screen, [OK] must
be pressed before sample analysis result screens can be viewed.
8 If no buttons are pressed in this screen then the display switches
to that in Figure 5.8 no further ID entry is possible.
9 After 45 seconds results will be displayed on List or Sample
menu. For more information of results refer to Section 5.9.
10 When NEW SAMPLE button returns to green, operator can
begin analysis of next sample.
35
5.5 Analyzing the Sample (Pre-dilution procedure)
Description This section describes how to analyze a pre-diluted sample through the “pre-
dilute” aspiration needle and how to use the dispense function. There are two
ways of pre-diluting a sample. The recommended pre-dilute method is using
the dispense function, which uses the factory calibrated dilution ratio of 1:225
(20 µl in 4.5 ml diluent). The second method is performing an external pre-
dilution using in-house dilution procedures, dilution ratios between 1:200 –
1:300, and re-calibrating system using selected dilution ratio.
Dilution Rates Dilution Rates: 1:200 – 1:300

and Ratios Recommended: 1:225 (20 µl in 4.5 ml diluent)
Time limitations Pre-dilute procedures are generally less precise than open and closed tube
procedures and results may vary depending on local laboratory procedures and
conditions. Blood cells may shrink and/or swell during the time between mixing
in the beaker and the actual analysis, resulting in compromised values of MCV,
MPV and the distribution between lymphocytes/mid-cells/ granulocytes (with
indirect effect on calculated parameters, e.g. HCT) . Thus, the time between
mixing and analysis should be minimized and under no circumstances exceed
60 minutes, since RBC, PLT, HGB and WBC may also be affected.
Externally Pre-  Pre-dilute volumes 4.5ml – 5.0ml. The dilution ratio must always be the
diluted volumes same as the dilution it is calibrated to in order to avoid erroneous result;
and preparation any dilution variation in an externally diluted sample will affect the
 parameter test results.
 Prepare pre-dilute sample according to internal documentation and
time limitations section above.


Dispense  This feature is to be used as a precision dispenser for dilution of
Function  blood samples.
 Dispense amount: 4.5 ml.
 Dilution: 20 µl in 4.5 ml diluent (1:225)
 Follow the instruction below:
Step Action
1 Press the [DISPENSE] button from the MENU tab.
Before pressing the pre-dilute start plate make sure that a waste
2 beaker is placed under the pre-dilute aspiration needle.
Press the pre-dilute start plate (right start lever) to enable dispense
3 mode. (The instrument will fill the waste beaker with a small
amount of diluent, this is to be discarded)
Fill the pre-dilute beaker by pressing the start plate again. If more
4 than one beaker is to be filled repeat this step.
36
5.5 Analyzing the Sample (Pre-dilute procedure) (Continued)
Menus

5 Prepare pre-dilute sample according to internal documentation and
time limitations section above.
6 To re-enter analyze mode press [CANCEL] and follow instructions
below to analyze pre-dilute samples.
Pre-dilute
Start by selecting pre-diluted sample beaker and follow the procedure below:
procedure
Step Action
1 Choose List, Sample, or Main menu to begin sample analysis.
Analyzer must be in one of these operation modes to aspirate.
2 Aspirate the pre-diluted sample through the pre-dilute aspiration
needle by pressing and holding the pre-dilute start plate behind the
right-side aspiration needle for five seconds. (See Figure 5.11)
Figure 5.11
3 Follow the instruction on the menu when to remove the sample
tube. A beep should be heard indicating sample removal.
4 Refer to Section 5.4 Steps 5 - 10 for remainder of
analysis sequence.
37
5.6 Analyzing the Sample (Micro Capillary Inlet, MCI)
Description This section describes how to analyze capillary whole blood samples with
the use of the Micro Capillary Inlet (MCI).
Micropipettes ONLY Boule supplied, plastic, high precision EDTA micropipettes should
be used when running MCI. Glass micropipettes can cause damage to
instrument if inserted incorrectly.
Starting
Follow the procedure below to operate MCI:
procedure
Step Action
2 Pull out the MCI adapter. (The instrument will give an instruction
to put back the MCI adapter to start).
3 Remove the previous sample micropipette. (If applicable)
4 Place the adapter on the table.
Drawing blood and sample preparation

Step Action
1 Puncture, using the Micro Lancet.
Figure 5.12
Always use gloves when in contact with potentially biohazardous materials.
Warning 2 Aspirate the sample as shown below.
Figure 5.13
38
5.6 Analyzing the Sample (Micro Capillary Inlet, MCI) (Continued)
 Fill the micropipette completely with fresh whole blood and wipe
 off excessive blood on the outside surface.
 Be careful not to wick blood from open ends of the micropipette.
Important
 Ignoring these instructions might cause incorrect and non-
reproducible results.
Insert the micropipette into the MCI device as shown below:
Figure 5.14
Insert the MCI into its holder and the instrument will
automatically start the analyzing sequence.
Figure 5.15
Do not remove MCI during sample aspiration or analysis. Removal prior
to completion of analysis may cause erroneous results.
Important
5 Refer to Section 5.4 Steps 6 - 10 for remainder of analysis
sequence.
Further To find more information, visit www.boule.se The Boule website contains
information and detailed video shots on how to use the MCI and cleaning procedures.
demos
39
5.7 Analyzing the Sample (Cap Piercing Device)
Description This section describes how to analyze whole blood samples using the
Cap Piercing Device.
Sample tube Most standard 3.0 ml to 4.5 ml tubes, with a maximum length of 77 mm,
description can be used in the cap piercing device. The minimum volume in the closed
tube should be approximately 1 ml.
The Cap Piercer can be damaged if incorrect sized tube is used.

Caution
Starting
Follow the procedure below to operate the Cap Piercing Device.
procedure
Step Action
2 Open door to cap piercer and insert vacuum tube upside down,
pressing the tube in place, aligning with lower support.
3

 Always use gloves when in contact with potentially biohazardous materials.
 Caution should be applied when handling the cap piercer. Handling
 and operation by unauthorized personnel may result in injury.
Warning  Insert the sample tube with lid facing downwards. Ignoring this
 instruction may damage the aspiration needle.
 4 Close the door to the cap piercer to begin sample analysis.
5 Refer to Section 5.4 Steps 6 - 10 for remainder of analysis sequence.
40
5.8 Analyzing the Sample (Auto Sampler)
Description This section describes how to analyze whole blood samples using the Auto
Sampler.
Sample tube Only standard 4.5 ml tubes can be used in the Auto Sampler. Do not use
description Sarstedt tubes. The minimum volume in the closed tube should
be approximately 1 ml.
Selecting Sample There are several ways to select the samples.

ID
If the Auto Sampler has a mounted barcode reader, the ID numbers
willbe read automatically. It is very important to line up barcode on tube
with barcode reader.
 If no barcode reader is connected the operator can enter the ID
numbers manually with the touch screen keyboard or barcode reader
 into a worklist.
 Samples can also be analyzed without identification, but then only
the sequence numbers will be present.
Starting
Follow the procedure below to operate the Auto Sampler:
procedure
Step Action
1 Unlock the center piece by turning it counterclockwise.
2 Load the vacuum tube samples by placing the capped end towards
outer edge of sample wheel and fitting it into designated slot.
3 Lock in samples by turning center piece clockwise.
4 Press [SAMPLER] button from the NEW SAMPLE Menu.
5 Press [START] to immediately begin analysis or press
[EXTRA MIX] if extra mixing of samples is needed.
 Do not touch sample wheels or samples during operation.
 Handling and operation by unauthorized personnel may result in injury.
Warning 6 Auto sampler begins analysis with the sample tube placed in
the lowest position number.

7 List or Sample Menu will appear when analysis is complete.
41
5.9 Results
Description This section describes the information that can be obtained from the sample
analysis results.
After sample After a sample has been analyzed the result information can be viewed in the
analyze following three screen displays:
Sample View 1
Total WBC count and WBC histogram

differential values
HGB parameters
RBC histogram
Total RBC count and

RBC parameters PLT histogram
PLT count and PLT parameters
Figure 5.20
Sample View 2
Analysis mode
Sample ID and analysis
profile
Primary Diagnostic
Parameters
Press on to view
Displays date and time of different views of
sample analysis, and WBC same sample.
and RBC counting times.
Use these buttons to scroll to

previous and next samples.
Figure 5.21
42
5.9 Results (Continued)
Sample View 3
Normal Range display

with sample results.
Sample results
Green bar = Results within Range

Flag and Warning
Indicator
Red bar = Results Out -of-Range

Press to print current
sample analysis.
Figure 5.22
43
Section 6: Quality Control (QC) and Blood Control
Memory
Section Overview
Introduction The Swelab Alfa is equipped with a QC memory capable of displaying and
printing X-B and Levey Jennings plots.
Topic See Page

Quality Control (QC) 44
Levey-Jennings Plots 46
Initialization and Use of X-B Function 47
6.1 Quality Control (QC)
Introduction This section describes the procedures to be performed for running control
samples.
QC Menu and Follow the instruction below to access the QC menu and to input
CBD input Control/Calibrator Blood Definitions (CBD) from the Assay sheet.
Step Action
1 Enter the QC menu by pressing [QC] from the menu tab.
2 Press [ENTER CON/CAL].
3 Refer to the Assay sheet for instructions on how to input control
definitions. (These pages are delivered with authorized Boule controls).

Note 12 different CBD´s from Boule can be stored simultaneously.
When renewing the definitions, the previously scanned CBD´s will be
removed in a chronological order starting with the first entered CBD.
44
6.1 Quality Control (QC) (Continued)
Control Analysis It is advisable that the performance of the Swelab Alfa system is checked
daily with a certified blood control authorized by Boule. Comparing the
analyzer results to the known values on the Boule control assay sheet is a
good assurance that the system is functioning properly.
 Handle and prepare controls in accordance to control package insert.

 Never use an open vial longer than recommended by the manufacturer
 or subject any vial to excessive heat or agitation.
Important  Wipe the aspiration needle with a clean, dry tissue before each control run.
Not following this discipline might lead to decreasing parameter values.


 As there are no assurances of the absence of HIV, Hepatitis B or C
viruses or other infectious agents in blood samples, controls, and
Warning  calibrators these products should be handled as potentially biohazardous.
Step Action
1 Follow directions on Assay Sheet to scan in values of CBDs.
2 Choose either List, Sample, or Main Menu to begin
control analysis.
3 Using installed barcode reader, scan the Control ID from the
blood control vial label.
4 Aspirate the blood control and wait for the results. The Swelab
Alfa will identify this ID and match the results with the
previously defined control blood definitions.
Search Function Each blood control type can be found by control definition (Lot number
and level), date or sequence number.
Step Action
1 Enter the QC menu and press [VIEW CON/CAL].
2 Input the search criteria to be used.
3 Pressing on the SEQ bar will display Figure 6.4, in which one
particular lot or level can be selected.
45
6.1 Quality Control (QC) (Continued)

4 Press the [SAMPLE] or [LIST] buttons to display the
selected samples.
6.2 Levey-Jennings Plots
Procedure This section describes selecting and viewing Levey-Jennings Plots.

instruction
L-J Plots Levey-Jennings (L-J) plots are used to monitor the long term stability of the
instrument using Boule blood controls.
Blood controls To be able to use L-J plots, the Control/Calibrator Blood Definition for the
blood controls, must be scanned with the installed barcode reader or manual
entered in. Follow direction on Assay Sheet to scan in values of CBDs.
Displaying To display the L-J plots, follow the instructions below:

L-J Plots
Step Action
1 Enter the QC menu and press [VIEW CON/CAL].
2 Scan the barcode label on the blood control tube, with the
barcode reader, select control from Select Con/Cal Sample
Menu, or manually enter in value.
3 Press [L-J VIEW] to display the Levey - Jennings plots.
46
6.2 Levey-Jennings Plots (Continued)
L-J plot The image below is constructed from several samples and will not
Diagrams be shown as below until a sufficient amount of samples have been
analyzed.
Figure 6.5
4 Scroll through parameters by choosing [MORE].
5 Print diagrams by choosing [PRINT].
Parameters The L-J plots are displayed for all parameters defined in the CBD page except
displayed on the WBC differential parameter “MID”.
L-J Plots
Note In case a control shows an error or warning flag SE, DE, FD, OF, LO, HI, NG,
TU, TL or TB; the parameter values of such control will not be included in the
L-J plots.
6.3 Initialization and Use of X-B Function
Description The X-B function in the Swelab Alfa follows strictly the Bull algorithm for
the parameters MCV, MCH and MCHC. These parameters should not drift
as a function of time within a large patient population. The recommended
range setting is ± 3% from the expected mean value of these parameters.
47
6.3 Initialization and Use of X-B Function (Continued)
Step Action
1 Enter the QC menu and press [VIEW Xb STATS].
2 Select X-b points by Date or by default all sample data is selected.
3 Press [LJ VIEW] to display Xb L – J diagrams.
Xb L-J The image below is constructed from several samples and will not
Diagrams be shown as below until a sufficient amount of samples have been
analyzed.

4 Select [MORE] to view selected conditions and matched ranges.
5 Print diagrams by choosing [PRINT].
6 To change ranges on Xb Diagrams go to Setup Menu 3 and press
[XB RANGE SETUP]. Here operator can change low and high
ranges on the three parameters.
Reference Bull BS, Hay KL. The blood count, its quality control and related methods: X-bar calibration
and control of the multichannel hematology analysers. In: Clangoring I. editor. Laboratory
Hematology: An account of Laboratory Techniques. Edinburgh.
48
Section 7: Calibration
Section Overview
Introduction This section describes the step-by-step procedure for calibration of the Swelab
Alfa. The instrument has been calibrated by Boule prior to shipment. Good
laboratory practice, however, requires regular checks and calibration of the
measured parameters
Topic See Page

Preparations before calibration 49
Calibration 50
7.1 Preparations before calibration
Before  It is advisable that the performance of the Swelab Alfa system is

Calibration
 checked daily with a certified blood control authorized by Boule.
 Analyze control blood once in the open tube mode and compare results
 with the assigned values prior to calibration.
 Verify that nothing is erratic with the control blood, the reagents, or
 the instrument before calibrating instrument.
 Prior to calibration print Calibration Log. Select [ADVANCED] from
Main Menu, then [CALIBRATION], then [CALIBRATION LOG], and
then [PRINT].


 Calibration operator must fulfill Operator Requirements in Preface Section.
 Handle and prepare controls in accordance to the control package insert.
 Never use an open vial longer than recommended by the manufacturer
 or subject any vial to excessive heat or agitation.
Important  Wipe the aspiration needle with a clean, dry tissue before each
calibrator run. Not following this discipline might lead to decreasing
parameter values.


 As there are no assurances of the absence of HIV, Hepatitis B or C
viruses or other infectious agents in blood samples, controls, and
calibrators these products should be handled as potentially biohazardous.
Warning
49
7.2 Calibration
Input calibrator Follow the instruction in Section 6.1 Quality Control to access the QC
definitions menu and to input Control/Calibrator Blood Definitions (CBD) from the
Assay sheet.
Whole Blood The following instructions calibrate Open Tube, Cap Piercer, and
Calibration Auto Sampler modes. Follow the instructions below to calibrate:
Step Action
1 Follow directions on Assay Sheet to scan in calibrator definitions.
2 Choose either List, Sample, or Main menu to begin calibrator analysis.
3 Using installed barcode reader, scan the Calibrator ID from the
calibrator vial label.
4 To perform calibration, it is recommended that five calibration
analyses be performed in consecutive order through the open tube
mode.
Important
5 When analyses are complete press [ADVANCED] from the MENU
tab.
6 Press [CALIBRATION] and then choose [WHOLE BLOOD].

Note: Calibration analysis must be last analysis performed on
instrument for parameter values to be shown in calibration menus. (e.g.
no values will show if in the middle of calibration a patient sample
analysis was performed)
7 Scroll through parameter screens by using the [MORE] button and
verify that the CVs for the following parameters:
RBC < 2.2
MCV < 1.8
PLT < 5.8
HGB < 1.8
WBC < 4.2
50
7.2 Calibration (Continued)
8 If CV values are not within range operator will be unable to perform

calibration. (Analyses with flags will automatically inactivate that
analysis from the CV calculation and depending on flag may not be
stored on list at all.) If a know sample handling error or erroneous
result is present, then sample can be inactivated by pressing button to
the left of that particular analysis and changing to empty brackets [ ].
9 If all parameters have acceptable CVs proceed to next step, if
not rerun calibration following steps above.
10 The new calibration factor can be entered in three ways.
 The recommended method is to select the [USE CAL]
button which will automatically calculated the new
calibration factor using target range from CBD.
 The second method, if no calibrator is available, is to perform
Steps 4-9 using a sample with target values from a CBD or
determining target values using a reference analyzer or a
microscope method with an in-house sample. The target values
can be entered selecting the [SET TARGET VALUE] button
 and manually entering in the values.
 The third method is to manually calculate and enter in calibration
factor. This method should only be used with instruction from
 local distributor or authorized service technician.
11 In the first and second methods the calibration factor is
automatically calculated once either the [USE CAL] button is
pressed or target value is entered.
12 Once calibration factor has been entered using one of the methods
above, operator will be prompted to enter a 4-digit Operator ID
(Operator ID is recommended for in-house records of calibration
operator but not required) and Calibration Code (REQUIRED)
before the new value can be changed or updated.
NOTECalibration Code prompt is displayed only once per calibration
sequence when [USE CAL], [TARGET VALUE], or [NEW
CAL FACTOR] buttons are pressed.
13 Authorized operator can update or change calibration factor
by inputting the Calibration Code [2576].
Figure 7.3
51
7.2 Calibration (Continued)
14 Perform steps 9-12 for RBC, MCV, PLT, MPV, HGB, and WBC
parameters. To move to the next parameter press [MORE].
15 It is recommended to not change preset calibration factors for
RDW%, RDWa, and PDW. If necessary, please contact local
distributor or Boule service technician for procedure.
16 Once parameters are calibrated, a screen will be displayed asking
operator if a calibration report is wanted, [SEND], [PRINT], or
[EXIT] can be selected.
Figure 7.4
17 It is recommended to run controls after calibration to verify that all
parameters have been calibrated correctly. See section 6.1 to
perform QC.
Capillary Device To calibrate MCI follow Steps 1-16 above except select [CALIBRATION]
Calibration and then choose [CAPILLARY DEVICE] instead of Whole Blood
calibration in Step 6 and use MCI mode for analysis.
Pre-dilute To calibrate pre-dilute follow Steps 1-16 above except select

Calibration [CALIBRATION] and then choose [PREDILUTE] instead of Whole
Blood calibration in Step 6 and use pre-dilute mode for analysis.
52
Section 8: Cleaning, Maintenance & Transport
Section Overview
Introduction This section contains information that is crucial for maintaining, transporting
and storing the Swelab Alfa.
Contents This section contains the following topics.
Topic See Page

Daily Cleaning 53
Monthly Cleaning 54
Six (6) Month Cleaning 55
Instrument Maintenance 56
Re-location of instrument (within the laboratory) 56
Short Term Transport (<12h) 57
Re-packaging and Long Term Transport 57
Permanent Shut-Down and Storage 58
Disposal Information 59
8.1 Daily Cleaning
Description The majority of the instruments cleaning procedures are automated to keep
the user maintenance to an absolute minimum.
Always use gloves when in contact with potentially biohazardous materials

or parts of the instrument that might be contaminated with blood.
Warning
Cleaning
The Daily Cleaning takes only a few minutes, the instructions are as follows:
Procedure
Step Action
1 Clean the aspiration needles using a paper tissue with a
70% alcohol solution.
2 Remove possible traces of salt crystals or blood using a paper
tissue with a disinfecting solution.
53
8.2 Monthly Cleaning
Description This section describes the cleaning procedure to be used to secure the correct
function of the instrument on a monthly basis.
Cleaning The Monthly Cleaning procedure takes approximately 10 minutes, instructions

procedure are as follows:
Step Action
1 Clean the aspiration needles using a paper tissue with a
70% alcohol solution.
2 Fill a cup with 10 ml 2% hypochlorite (bleach), certified by Boule.
3 Aspirate the hypochlorite as a whole blood sample.
4 Repeat step 2 but aspirate the hypochlorite as a pre-diluted sample.
5 Run 2 blank samples by aspirating 10 ml diluent as a whole
blood sample.
6 Repeat step 5, but aspirate diluent as a pre-diluted sample.
Clot Prevention This process will decrease the risk of system to build up debris material in
the instrument system. This should be preformed at least once a month or
every 1000 samples. This procedure will take 15 minutes to complete.
 Once this procedure is started the operator will be unable to abort the
 cycle until it is completed.
 Prematurely aborted the cycle could cause erroneous patient results if system
Importantis not cleaned properly.
Step Action
1 Fill a small container with 5 ml of Enzymatic Cleaner.
(Enzymatic Cleaner from the cleaning kit can be used.)
2 From Main Menu press [ADVANCED] and then
press [MAINTENANCE].
3 Hold the container under the OT needle, submerged in cleaner,
press [CLOT PREVENTION] and then [OK] to confirm. Do not
remove container with cleaner for at least 5 seconds after
aspiration has stopped.
4 The system will then perform the cleaning process, and upon
completion instrument is ready for next sample analysis.
54
8.3 Six (6) Month Cleaning
Description To increase the life of internal tubing in the instrument, the following cleaning
procedure is strongly recommended.
Cleaning  Press [ADVANCED] from Main menu, then press [MAINTENANCE], and
Procedure then press [CLEAN CYCLE] to enter the Cleaning Menu.
 Follow the instruction for the Boule Cleaning kit to clean the instrument.
(Instructions for use are supplied with the Boule Cleaning kit solutions).
 The Six Month Cleaning procedure takes approximately one hour and 15
minutes to complete.
Figure 8.1 Figure 8.2 Figure 8.3
Boule Cleaning The Boule Cleaning Kit contains the following items:
Kit
 Hypochlorite (2%)
  Enzymatic cleaner
 Detergent cleaner
Cleaning Depending on daily sample analyses, it is recommended that the

Interval following cleaning intervals be followed:
Less than 50 samples/day = every six months
More than 50 samples/day = every three
months 100 – 200 samples/day = every month
55
8.4 Instrument Maintenance
Description This section describes the maintenance that is required to maintain and
increase the life of the instrument. Refer to local distributor for
warranty requirements.
Maintenance The maintenance should be performed at the following intervals by

local distributor or authorized service technician:
  1 year or 20,000 samples
 2 years or 40,000 samples
 Auto Sampler only (every 5,000 samples)
8.5 Re-location of instrument (within the laboratory)
Description This section describes the procedure performed to move the instrument
over very short distances. (From table to table).
Before the If the instrument is in “standby” mode do not unplug instrument. Make
re-location sure that the instrument is in Sample or List menu before turning off.
1. Do not detach the reagent level sensors or waste tube, place the
sensors on top of the instrument when moving. (Avoid reagent level
sensor contact.)
2. Remove the waste tube from waste container or drain.
3. Disconnect all electrical connections.
Re-location Make sure that the instrument is lifted from beneath to avoid
unnecessary stress on the front cover.
After re-location 1. Place the waste tube in waste container or drain.

2. Reconnect the electrical connections.
3. Insert the level sensors back into the reagent containers.
56
8.6 Short Term Transport (<12h)
Description This section describes the procedure performed before transporting the
instrument over short distances. This procedure only describes the
preparations performed before transporting the instrument for less than
12 hours.
Empty System 1. Remove the reagent level sensors from the reagent containers.
2. Press [ADVANCED] button on MENU tab.
3. Press [MAINTENANCE] and then [EMPTY SYSTEM].
4. When empty procedure is complete, the following statement will appear
on screen: ‘System is empty and ready for fill or power off.’
5. Switch off power and then unplug analyzer.
Before the After instrument is powered off, detach reagent level sensors, waste tubing, and
re-location all electrical connections. Package all components carefully for transport.
Guidelines  The instrument should be transported in temperature conditions between

for transport  5 to 30 ºC (41 to 86 ºF)
 Humidity should be less than 80%.
8.7 Re-packaging and Long Term Transport (>12h)
Description This section describes the procedure when transporting or shutting down
the instrument for a longer period of time (>12 hours).
It is very important to follow the below instructions for preparing the

analyzer for long term transport or re-packaging, to avoid erroneous results
upon re-installation.
Important
57
8.7 Re-packaging and Long Term Transport (>12h) (Continued)
Long term Shut-Down
Step Action
1 Select [EMPTY SYSTEM] from MAINTENANCE Menu. See Section
7.5 “Short term transport” for emptying instructions.
2 Remove the reagent sensors from the reagent containers and follow the
instructions for the Boule cleaning kit. (Instruction is supplied with the
Boule cleaning kit solutions).
3 After completing the cleaning of the instrument, insert the reagent
sensors into distilled water. Select [FILL SYSTEM] from
MAINTENANCE Menu.
4 When the instrument has been filled with distilled water select
[EMPTY SYSTEM] from MAINTENANCE Menu.
5 When system is emptied, disconnect the main supply cable and other
connections such as reagent sensors and waste tubing.
6 Pack the instrument using the original shipping container.
7 Mark the container with DELICATE INSTRUMENT, FRAGILE and
THIS SIDE UP.
8 Follow Guidelines for transport below.
Guidelines for The instrument in its export package should fulfill the following
transport transport/storage conditions:
  Does not exceed - 40°C for ≥ 24 hours.
 Does not exceed a Dry heat of + 70°C for ≥ 24 hours.
 Dramatic change of temperature between - 40°C and + 30°C.
 Does not exceed a Damp heat steady state of 90% RH and +
40°C during 48 hours.
 Does not exceed a Damp heat cyclic of 90-100% RH and +
25°/+40°C 12+12 hours.
8.8 Permanent Shut-Down and Storage
Permanent Shut-
Down and Storing See Section 8.7 Long Term Transportation.
58
8.9 Disposal Information
Description Customers are advised to be knowledgeable of applicable local, state and

federal requirements, and the content of effluent streams, before disposing of
waste in public sewer systems.
Manufacturer  Place the instrument close to a waste container or drain suitable for disposal
Guidelines of used reagents.
 Check that the drainage is suitable for disposal of chemical and biological
waste.
 Check that the waste tubing is securely fastened in the drain.
Always use protective gloves when working with the waste container and
the waste tubing.
Mandatory Action
Disposal
 Used reagents
Materials  Reagents mixed with potentially biohazardous material
 Instrument and instrument components
 Controls and calibration material
Always use gloves when in contact with potentially biohazardous materials.

Warning
59
Section 9: Parameter Flags
Section Overview
Introduction The Swelab Alfa has several error and warning flags related to the measured
parameters. These flags alert the operator of possible pathologic samples and
parameter value errors.
Topic See Page

Short Description of Flags and Troubleshooting 60
Detailed Description of Flags 62
Flagging Capabilities 65
9.1 Short Description of Flags and Troubleshooting
Description The instrument has several parameter error flags related to the measured
parameters. The flags are shown on the display and printouts.
Resolving Error The sample should be re-analyzed. If the problem persists see list below to
Flags identify the issue and/or refer to Section 12 Troubleshooting.
Note Note that a parameter that is outside the “Normal Range”, refer to Section 9.4
for User Interface setup, is either marked with “H” or “L” on the printout and
display to indicate if the value is higher or lower than the pre-set “Normal
Range” values.
60
9.1 Short Description of Flags and Troubleshooting (Continued)
Parameter Flags
Flag Cause Action

TU Blockage in aperture Run a “Prime cycle”, before re-analyzing the sample.
TL Blockage in aperture Run a “Prime cycle”, before re-analyzing the sample.
ST Counting time too short Run a “Prime cycle”, before re-analyzing the sample.
TB Air bubbles present in system Run a “Prime cycle”, before re-analyzing the sample.
 Air bubbles
OR  Electrical disturbances Re-analyze sample
 Incomplete lysing
 Clogging
 Air bubbles
SE Re-analyze sample
 Electrical disturbances
 Incomplete lysing
 Air bubbles
 Electrical disturbances
DE  Incomplete lysing Re-analyze sample
 Incorrect gain settings
 Pathological blood sample
FD Insufficient cell separation between Re-analyze sample
RBC and PLT ranges
HS HGB readings vary too much Re-analyze sample
HH HGB light levels too high Run a “Prime cycle”, before re-analyzing the sample.
HL HGB light levels too low Run a “Prime cycle”, before re-analyzing the sample.
Switch off the instrument and switch it back on after
HO HGB offset level error 3 seconds, and then re-analyze sample
HGB reading has a higher light
HN level than a “blank” Re-analyze sample
NM
OM
TM WBC differential abnormality Blood sample too old or pathological sample
BD
AF Aspiration failure Re-analyze sample
Re-analyze sample
DF Diluent pipette fill error (Verify instrument is filled)
DP Diluent pipette emptying error Re-analyze sample
LF Lyse pipette fill error Re-analyze sample
LP Lyse pipette emptying error Re-analyze sample
TE Liquid transfer error Re-analyze sample
EC Expired control blood Use a fresh blood control
NR No Reagent Check reagent levels
ER Expired Reagent Use a new lot of reagents
61
9.2 Detailed Description of Flags
Description This section covers the full description of the parameter warning and error flags
that might occur. The list below is in order of the severity of the flag.
TU “Timeout upper detector” (RBC, PLT, WBC)

The liquid meniscus in the measuring tube passed the lower detector but never
passed the upper one.
TL “Timeout lower detector” (RBC, PLT, WBC)

The liquid meniscus in the measuring tube never passed the lower detector.
ST “Short counting time error” (RBC, PLT, WBC)

The time for the liquid meniscus to pass from the lower to the upper detector is
unreasonably short.
TB “Tube bubbles error” (RBC, PLT, WBC)

Air bubbles were detected by the start detector in the diluent column.
OR “Cell counting overrun error” (RBC, PLT, WBC)

The cell pulses arrived faster than the instrument could process them. Possible
reasons might be air bubbles, electrical disturbances or incomplete lysing.
Note: Filtered away cell pulses might raise the OR flag, so it might not be possible
to see them in the histograms or the result parameters. This is a hard limit
determined by the software.
SE “Statistical error/flow rate variation error” (RBC, PLT, WBC)

The rate of cell pulses per time unit varies too much. Possible reasons might be
clogging, air bubbles, electrical disturbances or difficult to lyse cells.
Note: Filtered away cells might raise the SE flag, so it might not be possible to see
them in the histograms or the result parameters.
DE “Distribution error” (RBC, PLT, WBC)

The size distribution of the cell pulses departs from the expected one. Possible
reasons might be air bubbles, electrical disturbances, difficult to lyse cells or an
incorrect gain setting.
FD “Floating discriminator error” (PLT)

It was not possible to find the correct position for the floating RBC/PLT
distribution curve. This flag often occurs on low PLT counts. The FD flag should
only be reported if the corresponding parameter (PLT) value is high enough.
62
9.2 Detailed Description of Flags (Continued)
HS “HGB statistical error” (HGB)

Individual HGB readings vary too much.
HH “HGB high level error” (HGB)

The HGB blank or sample readings reported a too high light level.
HL “HGB low level error” (HGB)

The HGB blank or sample readings reported a light level that was too low.
HO “HGB offset error” (HGB)

The HGB dark (offset) reading reported a light level that was too high or too low.
HN “HGB negative value error” (HGB)

The HGB sample reading reported more light than the blank reading. This gives a
negative HGB value.
NM “No WBC mode error” (LYM, MID, GRAN)

There was no mode in the WBC distribution between the LYM-L and GRAN-H
settings.
OM “One WBC mode error” (LYM, MID, GRAN)

There was only one mode in the WBC distribution between the LYM-L and
GRAN-H settings. Often in pathological samples with granulocytosis or
lymphocytosis a blood smear is recommended.
TM “Triple WBC mode error” (LYM, MID, GRAN)

There were more than two modes in the WBC distribution between the LYM-L and
GRAN-H settings.
BD “WBC bad distribution error” (LYM, MID, GRAN)

The calculated populations for LYM, MID, GRAN overlap too much. Often in
pathological samples with granulocytosis or lymphocytosis a blood smear is
recommended.
AF “Aspiration failure” (Whole blood, Pre-dilute)

Possible reasons for AF flag include a short sample, clogging or air bubbles in
sample tube. Note: This flag is also displayed when running a background count
(blank) without selecting the background analysis profile.
63
9.2 Detailed Description of Flags (Continued)
DF “Diluent pipette fill error” (RBC, PLT, WBC)

The instrument detected an abnormality during one of the fill cycles of the diluent
pipette. Reasons for flagging might be timeout, short time or bubbles at the upper
detector.
DP “Diluent pipette emptying error” (RBC, PLT, WBC)

The instrument detected an abnormality during one of the empty cycles of the
diluent pipette. Reasons for flagging might be timeout, short time or liquid not
detected at the lower detector.
LF “Lyse pipette fill error” (WBC)

The instrument detected an abnormality during the fill cycle of the lyse pipette.
Reasons for flagging might be timeout, short time or bubbles at the upper detector.
LP “Lyse pipette emptying error” (WBC)

The instrument detected an abnormality during the empty cycle of the lyse pipette.
Reasons for flagging might be timeout, short time or liquid not detected at the
lower detector.
TE “Liquid transfer error” (RBC, PLT, WBC)

The instrument detected an abnormality during the emptying of the first dilution
from the mixing beaker. Reasons for flagging might be timeout, or too short of a
transfer time.
EC “Expired control” (RBC, PLT, WBC, LYM/MID/GRAN)

A control blood was used past its expiry date.
NR “No Reagent” (RBC, PLT, HGB,WBC)

The instrument’s capacity counter has gone below zero and no reagent is detected.
Reason for no reagent may include empty reagent container or reagent level sensor
not inserted correctly into reagent container.
ER “Expired Reagent” (RBC, PLT, HGB,WBC)

The reagent was used past its expiry date. Change to a non-expired lot of reagent.
64
9.3 Flagging Capabilities
Description This section describes the limitations of the flagging capabilities of the
Swelab Alfa series.
Abnormalities All samples with anomalies and /or abnormal distributions signaled by the
instrument should be analyzed manually by a blood smear. Pathological cells
may vary in their stability towards lysing of their cytoplasmic membranes
compared to normal cells, which may cause aberrations in the automated
analysis. This also applies to the presence of normal non-pathological cells
that have been subjected to chemotherapy or other treatments.
65
Section 10: Technology
Section Overview
Introduction This section describes the different methods and principles of measurement
and calculations.
Topic See Page

Measuring Principles 66
Counting Time RBC & WBC 67
WBC Differentials 68
10.1 Measuring Principles
Description This section describes the measuring principles of the Swelab Alfa.
General The measuring principles of the Swelab Alfa are based on impedance and
Measuring spectrophotometry principles.
Principles
Whole Blood The number of cells for determining RBC and WBC values are counted from a
Dilution suspension of 1:40,000 for the RBC and 1:400 for the WBC dilution ratio of
whole blood.
Theoretical If a sample contains 5 million red blood cells per µl, a dilution of 1:40 000
Principles will give a final concentration of 5 million divided by 40,000 = 125 cells per
(RBC Example) µl. Each µl containing 125 cells, drawn through the aperture, will generate 125
pulses.
66
10.1 Measuring Principles (Continued)
Measured The measured volume drawn through the aperture is 270 µl (Manufacturer
Volumes calibrated). Based on the assumption made above, the system will count
(Example) 270*125 = 33,750 pulses. The analyzer uses a fixed division factor of 67.5
calculated as 33,750 / 67.5 = 500 which is the correct value. (Based upon
this calculation the instrument would show RBC = 5.0x106 cells/µl).
Stop sensor
Measured Flow
Volume
Start sensor
Figure 10.1
Theoretical The calculation principle for white blood cells is the same but with a
Principles (WBC difference in dilution ratio and cell quantity. An example of this could be
Example) as follows: 5,000 cells/ µl diluted 1:400 =12.5.
10.2 Counting Time RBC & WBC
Description The counting time is defined as being the time needed for the sample to fill the
metering unit from the start to the stop detector.
Counting Time The normal counting time limits for the RBC and WBC metering units are
Limits between 13 – 18 seconds and 10 – 13 seconds respectively. If the counting
time is below or exceeds the above mentioned limits, the flag “LO” or “HI”
will be displayed.
Note The ´counting time´ is not related to the actual result. Atmospheric pressure
variations, protein built up within the orifice (aperture) and other secondary
effects that might cause pressure changes will NOT affect the counted
parameters RBC, PLT and WBC.
67
10.3 WBC Differentials
Description The Swelab Alfa uses a fixed discriminator technology.
Fixed The differentiation of the WBC cells into lymphocytes, mid-cells and granulo-
Discriminators cytes is presented in the number of cells per liter or cubic millimeter and in the
percentage of the total number of WBC cells. The MID discriminator of WBC
is set to 140 and 180 fl. The WBC histogram is automatically adjusted
depending on the number of cells, i.e. expanded for low values and
compressed for high values.
Volume lysed WBC (fl)

Figure 10.2 (Normal distribution curve)
Differential  LYM region (small size cells): Ranges from 30 to 150 fl. Cells in this
parameters area typically correlate to lymphocytes. Other cell types that could locate
in this region are nucleated red blood cells, clumped platelets, macrocyte
platelets, variant (atypical) lymphocytes or blasts.

 MID region (mid size cells): Ranges from 140 to 180 fl. Cells in this
area typically correlate to monocytes, eosinophils and basophils and
also degranulated neutrophils, precursor cells, blasts and plasmacytes.

 GRA region (large size cells): Ranges from 210 to 600 fl. Cells in this area
typically correlate to neutrophils. In approximately 20% of the samples
eosi-nophils can also locate in this region. Precursor granulocytic cells,
especially bands, have a tendency to locate close to the mid cell region.
68
Section 11: Specifications
Section Overview
Introduction This section describes the specifications for the Swelab Alfa and its parameters.
Topic See Page

General 69
Short List of Specifications 70
Parameter Ranges 71
Reagent and Reagent Consumption 71
11.1 General
Description This section describes the Swelab Alfa and its parts in general.
User The operator works with a menu from which the desired program is chosen,
Environment e.g. discriminator settings.
Reagents Two external reagent reservoirs are used:

 Isotonic diluent
 Hemolyzing reagent
Technology The Swelab Alfa is a fully automatic hematology analyzer designed to

measure up to 20 parameters using whole blood from an open inlet, closed
tubes, 20µl micro pipettes or pre-diluted blood.
3-Part WBC The instrument performs a 3-part WBC differential by means of a cyanide free
hemolyzing reagent.
Protected A sample memory is available and protected against main power failures. The
Sample Memory sample memory also contains a search function with selective printing and QC
Options.
69
11.2 Short List of Specifications
Specifications (Short)
Measuring principle Impedance

RBC, WBC, PLT
Measuring principle HGB Photometer, Cyanide free method 535nm ±5nm
Programmable WBC Discriminator Yes
Sampling system Closed shear valve
Parameters reported RBC, MCV, HCT, PLT, MPV, HGB, MCH,
MCHC, WBC, RDW%, LYMF abs, MID abs,
GRAN abs, LYMPH%, MID%, GRAN%,
RDW abs, PDW abs, LPCR, PCT
Size distributions printed for RBC, PLT and WBC diff.
Aspirated blood volume ≤ 90 µl
(open tubes)
Blood volume using the Micro 20 µl
Capillary Inlet (MCI)
Pre-diluted mode 1:200 to 1:250 using min. 20 µl
e.g. 20 µl to 5 ml diluent (1:225)
LCD Graphical color touch screen, 240 columns x
320 rows
Keyboard Virtual incorporated keyboard (External
keyboard possible)
Number of Samples per hour 67 samples
QC capabilities Mean, SD, CV, Levey-Jennings plots and X-B
with >10,000 samples history
HGB correction on high WBC counts Yes
Warning flags on parameter Yes
abnormalities
Floating discriminator RBC/PLT Yes (position printed)
Automatic HGB blank on each sample Yes
Carry over RBC, HGB, WBC ≤ 1%, PLT ≤ 2%
Bar-code reader input Yes
Serial output Yes (Must conform to standard EN 60950)
Main Voltage / Fuses 230V Fuse 5x20mm T1,6 A, 250V
120V Fuse 5x20mm T3,15A, 250V
Power consumption Max 100VA
Power consumption (stand-by) Max 20VA
Frequency 50 / 60 HZ
Built-in test / adjustment programs Yes
Temperature 18 - 32°C (64 - 90°F)
Humidity (none condensing) Up to 80%
Dimensions HxWxD 410x290x460 mm
Weight ≤ 18 kg (Standard Version)
70
11.3 Parameter Ranges
Linearity Measured according to Boule I-1040 Section 8, based on Standard EP6-A.
Parameter Maximum Non-Linearity Within the following range:

WBC 3% 0 – 80.0 x 109/l
RBC 2% 0 – 7.00 x 1012/l
PLT Not Detected 0 – 1800 x 109/l
HGB 3% 0 - 25.0 g/dl
Measuring Range
The correlation is performed using a Bayer/Advia 120 as reference.
and Correlation
Parameter Measuring range Correlation

WBC 0 - 99.9 x109/l R > 0.97
RBC 0 – 14 x1012/l R > 0.98
MCV 15 – 250 fl R > 0.98
PLT 0 - 1999 x109/l R > 0.95
HGB 0 – 99.9 g/dl R > 0.98
Reproducibility Measured according to Boule I-1040 Section 7, based on Standard EP6-A.
Reproducibility (typical)
Measured as an average of 10 measurements each on 3 different vein K2-
EDTA collected normal samples, on three instruments. Values shown
have been corrected to show 95% confidence limits.
Parameter X-mean (CGS units) CV (%)
WBC 8.4 < 3.5
RBC 4.34 < 1.8
MCV 94.4 < 1.5
PLT 313 < 4.8
HGB 13.7 < 1.5
11.4 Reagents and Reagent Consumption
Description This section describes the reagent consumption for the Swelab
Alfa depending on a sample per day calculation.
Supported Use only Boule authorized reagents. Erroneous results and damage
Reagents may occur if other reagents are used.
Diluent
Approximately 22 ml per analysis cycle
Consumption
71
11.4 Reagents and Reagent Consumption (Continued)
Lyse
Approximately 4.5 ml per analysis cycle.
Consumption
Consumption The consumption can be approximately calculated depending on the number

Calculation of samples per day as shown on the graphs below. The figures, presented in
the graphs, assume one exit standby and one wash per day.
The consumption relation between the Isotonic diluent and the
hemolyzing reagent is 5:1, based on 50 samples per day.
Diluent
Consumption Diluent Consumption
30
25
20
ml/sample
15
10
0
25 50 75 100 125 150 200
Samples/day
Figure 11.1
Lyse
Consumption Lyse Consumption
6
4
ml/sample
0
25 50 75 100 125 150 200
Samples/day
Figure 11.2
Additional For additional information regarding the consumption of cleaning solutions

Information please refer to the Boule cleaning kit instruction. (Supplied with the Boule
cleaning kit).
72
Section 12: Troubleshooting
Section Overview
Introduction This section contains information needed to troubleshoot the Swelab Alfa
instrument.
Contents This Section contains the following topics:
Topic See Page

Communication Issues 73
General Information Displays 74
Warning Displays 78
Aspiration Issues 83
Troubleshooting Other Issues 85
12.1 Communication Issues
Description This section contains information regarding errors associated with

printers, barcode readers and serial data communication.
Printer Issues See Section 4.3 Printer Modes for further detail.
If Then Possible cause

The printout has unusual 1. Verify that printer type 1. New printer was connected but
layout or strange matches the printer being used. not matched with analyzer
characters. 2. Verify that the correct paper setup.
format has been selected for 2. Printer may need maintenance
the printer paper. or to be reset.
Results are not printing 1. Verify that Auto Print Mode is 1. Auto Print Mode was turned
out after sample or NOT set to ‘0’. off and not reset.
control analysis.
1. Printer Alarm message is 1. The printer is not connected to
displayed. the instrument or the printer
2. Printer is not ready to print, setup is incorrect.
wait unit printer has finished 2. The printer has not completed
with previous printout. last printout.
3. Verify that printer is connected
the instrument.
4. Verify that the setup of the
instrument is correct for the
printer in use.
73
12.1 Communication Issues (Continued)
1. The Printer is connected to 1. The printer has timed out.

the instrument and on, but not 2. Printer paper may need to
activated. be refilled.
2. Verify that printer is not 3. Incorrect setup for
in standby or offline. information transmission.
3. Verify that printer is set to
print and not serial port
only setup.
Serial Data Issues See Section 4.3 Data Communication for further detail.

The data sent does not 1. Make sure that the correct HW 1. Serial setup in analyzer is
seem correct handshake and Auto Send incorrect.
Mode has been selected.
Results are not being 1. Verify that Auto Print Mode is 1. Auto Print Mode was turned
sent to computer after NOT set to ‘0’. off and not reset.
sample analysis
Barcode Issues See Section 4.3 Barcode Setup for further detail.

Error message when 1. Check control lot number is in 1. CBD from new lot of controls
trying to read ID on system. has not been scanned in.
control vial. 2. Verify that lot of control being 2. Control has expired.
used has been entered in 3. CBD scanned in incorrectly.
correctly from supplied CBD.
Error message when 1. Verify that correct barcode 1. New barcode was connected
trying to read ID on format has been selected. but did not match instrument
sample vial. setup.
12.2 General Information Displays
Description This section contains information regarding general information displays.
General General information displays are informative screen displays that appear after
Information a function has been completed. Instruction is then displayed for the operator
Displays on next step or function to be performed.
74
12.2 General Information Displays (Continued)
Standby, Power Down, and Power Up Informational Displays
The system is empty from all liquid The system is filled with liquid and is The system has not been used during
and prepared to be filled with other prepared for power off. Press [PWR the preset display saver time. Press
liquid or be stored away. Press UP] if you want to return the system [RESUME] to activate the
[FILL] if you want to refill system to active status or [EXIT] if you want instrument. Once activated, the
or [EXIT] if you want to return to to return to instrument menu. It is instrument is ready to perform an
instrument menu. No analyze can be recommended to use [ENTER analysis.
performed before the instrument is STANDBY] and that power is left on,
refilled with reagents. instead of using this feature.
Instrument will enter Standby mode The instrument is in the process of The system is in Standby. Press
in 2 minutes. Press [CANCEL] to going into Standby. Please wait. [EXIT STANDBY] to activate the
return to instrument menu. instrument. Once activated, the
instrument is ready to perform an
analysis.
75
Standby, Power Down, and Power Up Informational Displays
The system is preparing the The instrument is in process of The instrument is in process
instrument for analysis mode. If the powering down. Please wait. of powering up. Please wait.
background check is activated,
background result will be displayed.
Once activated, the instrument is
ready to perform an analysis.
Diluent Dispense Informational Displays
The instrument is preparing to The instrument is now dispensing The instrument is exiting
dispense diluent. Dispose of 4.5 ml of diluent. Please wait. dispense function. Please wait.
first dispense for best results.
76
Cycle In Progress Informational Display
The instrument is priming the The instrument is filling the system. The instrument is cleaning the Open
system. Please wait. Please wait. Tube needle. Please wait.
Every twelve hour the instrument The system has finished the count of The printer is in the process of
performs a wash of the system. cells and displays the results. The printing. Please wait.
During wash cycle the instrument analysis cycle in not yet completed, as
can not be used for performing an the system still needs to perform wash
analysis. cycle for an accurate next sample
result. Please wait until the [NEW
SAMPLE] button is activated. If
needle was submerged in next sample
by mistake, perform a background
count before continuing with the next
analysis.
77
Reagent and Control Informational Displays
Instrument displays this notice to Instrument displays this notice to Instrument displays this notice to
inform operator that ComboPack inform operator that Diluent reagent inform operator that Lyse reagent
reagents will soon need to be will soon need to be changed. will soon need to be changed.
changed.
Instrument displays this notice The reagent barcodes were scanned in The CBDs were scanned in correctly
when reagent container or correctly using the barcode reader and using the barcode reader and the
containers need to be changed. Not the instrument has accepted the instrument has accepted the values.
changing reagents at this time could values.
cause erroneous results or possible
damage the instrument.
78
12.3 Warning Displays
Warning Warning displays appear after a function has been performed incorrectly or
Displays to inform the operator that further action is needed to complete the desired
task. The warning display describes the situation and instructs the operator
on next step or function to resolve issue.
System Power Down Warning Displays
The system has been switched off The system was switched off The system was manually switched
for a long time period. The incorrectly. Perform a prime to off with system emptied of reagents.
instrument has been powered down prepare the system for analysis. Check Fill the instrument with reagents to
with all valves open and filled with method for correct instrument power prepare for analysis or exit if only a
liquid. Empty and refill the system down procedure. search of instrument menus is
with reagents, and perform a needed.
background count.
The instrument has been switched The system was powered down with The regular 12 hour wash has failed.
off with power down function liquid in system and has been unused Make sure that reagent containers
before power was switched off. for long period of time. Perform the are filled and the detectors are
Perform a power up to prepare the cleaning procedure according to inserted correctly.
reagent system for analysis. cleaning kit instruction. Perform a
background check.
79
12.3 Warning Displays (Continued)
Reagent Warning Displays
The regular 12 hour wash has not The reagent container or containers are This message is displayed if reagent
been preformed. Check if reagent empty. Check if the containers are container or containers are empty
containers are empty and if the empty and if level sensors and reagent when coming out of Standby. Check
reagent detectors are in contact contact plugs are inserted correctly. if the containers are empty and if
with reagent. level sensors and reagent contact
plugs are inserted correctly.
ComboPack container needs to be Diluent container need to be changed. Lyse container needs to be changed.
changed. Not changing reagents Not changing reagents at this time Not changing reagents at this time
at this time could cause erroneous could cause erroneous results or could cause erroneous results or
results or possible damage the possible damage the instrument. possible damage the instrument.
instrument. Connect new reagent Connect new reagent container and Connect new reagent container and
container and scan in barcode on scan in barcode on container. scan in barcode on container.
container.
80
Barcode Warning Displays
No more space is available to scan CBD barcode scanning failed. The Reagent barcode scanning failed.
in new CBD. Follow the CBD or order of scanning in the Barcode printing or order of
recommendation or manually delete barcodes may have been incorrect. scanning in the barcodes may have
all the controls with same ID, to Verify that setups on the instrument been incorrect. Verify that setups on
free space for scanning the new match the required setup for the the instrument match the required
CBD. barcode reader. setup for the barcode reader.
Open Tube Warning Displays
The instrument was unable to wash The instrument was unable to wash The instrument is unable to wash the
the Open Tube aspiration needle. the Open Tube aspiration needle. Open Tube aspiration needle. Verify
Verify that tube is removed and Verify that tube is removed and wash that tube is removed and wash
wash device is in correct position, device is in correct position. It is device is in correct position. It is
then perform OT Wash. recommended that background count recommended that background count
is performed before next sample is performed before next sample
analysis. analysis.
81
Capillary Device Warning Displays
The MCI was opened during an The MCI was opened during a cycle The MCI holder was opened
inappropriate time. It is or analysis. Re-insert holder, and during an inappropriate menu. The
recommended to perform a follow suggested recommendation. MCI holder should only be opened
prime cycle before next analysis. in List, Sample or Main menu.
Cap Piercer and Auto Sampler Warning Displays
The Cap Piercer door was opened The aspiration wheel has been Three aspirations have been
before the CAP door lock had been interfered with during mixing. Press attempted. All have failed. Verify
activated. Close the Cap Piercer [OK] to return to the sample menu. that sample tubes contain at least
door to continue with the analysis. To proceed with the analyses press 1 ml of blood.
[CONTINUE] in Auto Sampler List
Menu.
82
A counting error has been detected in Incorrect calibration code was

Auto Sampler mode. Verify that tubes entered. See calibration section in
are in correct position and order. User’s Manual.
12.4 Aspiration Issues

Description This section contains information regarding errors associated with
aspiration and the aspiration needle.

No aspiration of sample 1. Verify that there are no leaks and tubing is 1. Blockage of tubing or leak
is taking place. connected properly and not kinked. causes sample to not be
2. Perform valve check in Service Menu pulled correctly through
3. Suggest performing clot removal shear valve.
procedure. See Appendix A. 2. Valve malfunction.
3. Clot in sample caused by
incorrect sample handling or
pathologic sample.
No cleaning of 1. Suggest cleaning upper area of aspiration 1. Sample tube is touching the
aspiration probe needle. upper part of the aspiration
2. Verify that there are no leaks and tubing needle when analyzing.
is connected properly and not kinked 2. Diluent is not flowing
correctly through tubing to
aspiration needle.
12.5 Troubleshooting Other Issues
Description See Troubleshooting Flowchart in Appendix A for other possible issues

that may arise. Areas on Flowcharts highlighted in dark grey should only
be performed by service technician or authorized personnel.
83
Index
A mixer ................................................................................ 23, 31
21, 36, 52, 70
Aspiration Issues ................................................... 73, 83 MPV ......................................................................
aspiration needle ......................... 32, 34, 36, 37, 40, 45, 49, 83 N
Assay sheet .......................................................... 44, 50
Auto Sampler ..................................... 31, 41, 50, 56, 82, 83 NEW SAMPLE ................................................. 32, 33, 35, 41, 77
B O
background count................................. 32, 63, 77, 79, 81, 87 Open Tube................................................... 31, 34, 35, 50, 77, 81
barcode.................. 24, 25, 33, 41, 45, 46, 50, 73, 74, 78, 80, 81 Operator ID ............................................................................. 51
barcode reader .................................... 25, 41, 45, 46, 50, 81 P
blood controls ............................................ 5, 6, 10, 32, 46
Parameter Ranges .............................................................. 69, 71
C PCT .................................................................................. 21, 70
calibration ......................................... 48, 49, 50, 51, 52, 59 PDW ............................................................................ 21, 52, 70
PLT...................... 13, 21, 29, 32, 36, 50, 52, 61, 62, 64, 67, 70, 71
Calibration Code........................................................ 51
75, 76, 79
calibrators ....................................... 5, 6, 10, 32, 34, 45, 49 Power Down.................................................................
7, 12, 13
Cap Piercer ............................................ 17, 40, 50, 70, 82 power supply..................................................................
75, 76
CBD ........................................... 44, 47, 50, 51, 74, 78, 81 Power Up ..........................................................................
36, 37, 52, 87

Cleaning ........................................................ 53, 54, 55 pre-dilute................................................................
16, 79, 82
Clot Prevention ................................................ 54, 85, 87 prime ...........................................................................
Clot Removal ........................................................... 85 printer .............................................. 13, 14, 24, 25, 30, 73, 74, 77
CV ............................................................... 51, 70, 71 Q
D 17, 44, 45, 46, 48, 50, 52, 69, 70
QC. ............................................
date/time function ...................................................... 24 R
DF. ............................................................... ….61, 64
Diluent Dispense ....................................................... 76 RBC................ 13, 21, 29, 32, 36, 50, 52, 61, 62, 64, 66, 67, 70, 71
Dilution Rates ........................................................... 36 RDW ........................................................................... 21, 52, 70
dispenser ................................................................. 36 RDWa..................................................................................... 21
Disposal......................................................... 15, 53, 59 reagent barcodes ...................................................................... 16
distributor.............................................4, 7, 13, 51, 52, 56 Reagent Consumption ........................................................ 69, 71
DP. ................................................................... 61, 64 reagent level sensor 14, 56
................................... ........................ .
reagents.................... 5, 6, 14, 16, 49, 59, 61, 64, 71, 75, 78, 79, 80
E
S
EDTA ........................................................... 31, 38, 71
Electrical Connections ............................................. 10, 12 safety features........................................................................ 5, 6
Emergency Procedure.................................................... 7 sample analysis........... 23, 31, 34, 35, 37, 38, 40, 42, 50, 54, 74, 81
erroneous results ................... 6, 7, 23, 31, 32, 34, 39, 57, 78, 80 Sample collection .................................................................... 31
Sample Memory ................................................................ 29, 69
F sample statistics....................................................................... 29
fill.......................................... 15, 16, 36, 57, 61, 64, 67, 87 Sample View ................................................................ ..... 42, 43
26, 74
fixed discriminator ..................................................... 68 Send Mode ........................................................................
30, 45
flags .........................................................51, 60, 62, 70 sequence number ...............................................................
serial output............................................................................. 26
G Service ................................................................. 4, 5, 13, 83, 87
service technician ................................................... 51, 52, 56, 83
General Information Displays .................. 73, 74, 75, 76, 77, 78 Setup................................................ 22, 23, 24, 25, 26, 28, 30, 74
GRAN.......................................................21, 63, 64, 70 Specifications .................................................................... 69, 70
H Standby ............................................................................. 75, 76
Storage.............................................................................. 53, 58
HCT ............................................................. 21, 36, 70 system flow....................................................................... 14, 20
HGB .............................. 21, 32, 36, 50, 52, 61, 63, 64, 70, 71
T
I
target values ............................................................................ 51
Installation...................................................... 10, 11, 13 TL................................................................................ 47, 61, 62
instrument settings ................................................. 22, 30 Transport...................................................................... 53, 57, 58
Troubleshooting............................................................ 60, 73, 83
L
TU. ............................................................................ ..47, 61, 62
language ............................................................. 23, 25
W
Levey-Jennings Plots ......................................... 44, 46, 47
LPCR................................................................. 21, 70 Warning Displays ........................................ 73, 79, 80, 81, 82, 83
LYM ........................................................21, 63, 64, 68 warning signs ............................................................................ 7
warranty .............................................................................. 5, 56
M 77
wash cycle...............................................................................
maintenance ................................................53, 56, 73, 87 waste.............................................. 6, 7, 15, 32, 36, 56, 57, 58, 59
MCH ............................................................ 21, 47, 70 waste tube ......................................................................... 15, 56
MCHC .......................................................... 21, 47, 70 WBC... 13, 21, 29, 32, 36, 47, 50, 52, 61, 62, 63, 64, 66, 67, 68, 69,
MCI ....................................... 10, 17, 31, 38, 39, 52, 70, 82 70, 71
MCV .......................................... 21, 36, 47, 50, 52, 70, 71 X
measuring principles ................................................... 66
Menu Structure ..................................................... 18, 19 X-B function ........................................................................... 47
micropipette ......................................................... 38, 39
MID ................................................ 21, 47, 63, 64, 68, 70
84
Appendix A
Clot Removal This process will help operator to remove a clot from the system. This should
only be used when the OT aspiration needle is blocked and Clot Prevention
procedure can not be performed. THIS SHOULD ONLY BE PERFORMED
BY A SERVICE TECHNICIAN OR AUTHORIZED PERSONNEL.
Step Action
1 Remove outer cover:
 Press release lever on underside of cover.
Figure 13.1
 While pressing release lever, place one hand on top of analyzer to stabilize
and then gently pull bottom of cover forward (only enough to slide pass
release lever)
 Place both hands on upper sides of cover and carefully pull towards you.
Figure 13.4
 Place cover aside.
85
CLOT REMOVAL PROCEDURE (Continued)
Step Action
 Be very careful when removing cover to not damage analyzer.
 Follow directions and do not force.
 Be aware of aspiration and pre-dilute needles.
Important
2 Prepare a syringe by attaching a piece of maintenance tubing to syringe tip and fill
syringe with 2% Hypochlorite solution. (Hypochlorite from the cleaning kit can be
used.)
3 Locate the Valve 27, the lower valve directly to the left of shear valve.
4 Locate the L (elbow) connector on the right-hand side of this valve and disconnect
the L connector from ONLY the tubing that is threaded through valve.
5 From Main Menu press [ADVANCED] and then press [SERVICE].
6 Attach prepared syringe tubing to L connector, press [CLOT REMOVAL], press
[OK], and gently apply pressure back and forth to syringe until clot is loosened.

7 Thoroughly flush tubing with Hypochlorite Solution until all obstructions
are removed.
Figure 13.7
8 Disconnect syringe and reattach L connector to valve tubing.
9 Replace analyzer cover:
 Carefully align top edge of analyzer and display with cover.
 Gently, partial push on upper part of cover to fit over display.
 Using both hands on sides of covers, slowly press on, fitting over
 aspiration plates.
 If aligned properly release lever will automatically click into place, there will be
no spacing between cover and display, and aspiration plates will move freely.
10 Once cover it replaced Exit out of Service menu. Press [MAINTENANCE]
and then perform two Clot Prevention cycles following instructions above.
11 Run a background count and check that it is within limits (See Section 5.2), and
if necessary a control to verify that clot removal was successful.
86
DF or DP ERRORS
Check for the following:

1. Level detector connection to back of analyzer are tight.
2. Leakage under instrument.
3. Level detector inserted correctly into box.
4. No pinch or kink in level detector
Perform a Prime, then

a background count
DONE
NO
NO Re-analyze
DF/DP flag? DF/DP flag?
sample
All highlighted areas of flowchart are to be

YES YES
performed by trained in-house technician
ONLY. Perform Level
Detector Test. in
Service Menu.
Remove back, right YES

Were all values 2
cover see instruction
(2 = liquid)?
in manual NO
Check that lower and upper tubing is

connected to measuring pipettes by
tightening tubing onto ends.
Perform a background Did liquid YES Did liquid stop at

count and watch liquid move up and down
upper detector?
in measuring chambers. in pipette?
YES NO
NO
Is there
YES Contact Service
any liquid in air
Representative
bin?
NO
1. Perform Valve Check YES Check and tighten

2. Contact Service and give DF/DP flag? Perform a
tubing on waste
Valve Check results background count bin
NO
DONE
87
Discordant Results
Questions to ask:
1. Was sample collected and handled properly?
2. Was the same sample used for both in-house and outside lab analysis?
3. Different blood draw and/or different tube?
4. Could the sample have been switched with another patient?
5. Could discordance be due to age changes during shipping or time periods
between blood draw and analysis (RBC swelling, platelet clumping,
deterioration of WBC for differential)?
Go to control out of
Are controls NO range Troubleshooting Repeat using correct
Check that sample is
within range?
YES Is MCHC protocol procedure
mixed correctly and no out-of-range?
hemolysis or lipemia is
present. YES NO
NO
NO Are all parameters YES Was calibration YES Was calibration
Is HGB recently protocol followed
Perform HGB YES discordant?
out-of-range? performed? correctly?
blank.
NO
NO YES
1. Verify by looking at
Is PLT
blood film. NO
2. Check sample for clots.
YES out-of-range? Change out Are reagent NO Were all
3. Review PLT histogram. reagent and parameters
levels ok?
re-run sample. low?
(verify bell-shaped curve)
NO
YES Perform
YES Maintenance
Is HCT low
Verify that sample is
mixed correctly and tube YES compared to Review differences that can Is monthly or 6- YES
spun PCV? be expected when comparing
has correct ratio of blood month Maintenance
results from same system,
to anticoagulant. due?
NO from different systems, etc.
NO
Are
Examine blood film Perform Clot
RBC and PLT both
high or both Prevention procedure
YES low? and rerun sample.
1. Check reagent level.

2. Run Orifice Clean cycle
NO YES
from Service Menu (possible
blockage of aperture) Is sample Are results still
3. Check if monthly or 6- YES Are pathological? discordant?
month Maintenance is due? WBC and HGB both
high or both
low? NO NO
YES
DONE
NO
Are
RBC and HGB
Contact Service
both low?
Representative
Contact Service
NO Representative
1. Verify by looking at blood film.

Rerun and/or Is WBC YES 2. Check sample for clots.
redraw sample. out-of-range? 3. Remix and check correct
sample handling followed.
88
Display Issues
Usual Cause:
1. Keypad flex-cable loose
2. Static electricity
3. Power Outage/Lightening
Verify/record with
clinic if power
surge was noted
Turn off analyzer with

On/Off switch and
All highlighted areas of flowchart then turn back on.
are to be performed by trained in-
house technician ONLY.
Is green power
NO Contact Service
light on front of
Representative
analyzer lit?
YES
Contact Service Touch screen and

Representative wait one minute.
YES
Is beep NO Is display YES

heard when screen DONE
visible?
is touched?
NO
Turn off analyzer with
On/Off switch.
Remove front cover,

see instruction in
manual.
YES
Check that keypad flex-

cable, behind top of Turn on analyzer with Is display NO Press
start lever. Is
screen, is firmly On/Off switch. visible?
beep heard?
pressed into connector.
YES NO
Contact Service
Representative
89
HIGH BACKGROUND COUNTS
Initial Procedure:
1. Check Diluent Lot Number and expiration date.
2. Check age of Diluent (i.e. when was it opened?)
3. Check that level sensors are pushed all the way to the bottom of the reagent containers and firmly
tightened on back of analyzer.
4. Check that level sensors are in correct reagent containers (red=diluent, yellow = lyse)
5. Check reagent level.
6. Check environmental condition (i.e. extreme temperature fluctuations?)
Run total of 3
backgrounds to See Clot Removal
verify procedure
YES
YES Did NO Are clots NO Perform Orifice Clean NO Did

DONE background background
visible ? in Maintenance menu
pass? pass?
YES
Did YES
background DONE
pass?
Repeat procedure NO Was procedure YES
using correct protocol followed correctly?
NO
YES Was Monthly or YES Were all Check Noise Test

6-Month Maintenance under Service
values '0'?
Run 2 Prime just performed? Menu
cycles followed
by a background NO
cycle. See Noise Issue
NO Flowchart
YES Did
DONE background Is maintenance YES Perform scheduled
pass? procedure scheduled to maintenance and re-
be performed? analyze background.
NO
Run 3 NO
backgrounds. Did
Try another box of NO
background
diluent.
pass?
Did NO YES
DONE
YES background Did YES
pass? background DONE
pass?
NO
Perform heated
detergent procedure,
using detergent from
6-month cleaning kit
Contact Service NO Did YES Run 2 Prime cycles

background followed by a
Representative
pass? background count
90
Noise Issues
Usual Cause:
1. Bad electrical outlet in clinic
2. Power Outage/Lightening
Is SE flag YES See SE flag

troubleshooting
present?
protocol
NO
Perform Noise Ask customer to

Test, under tighten screws on
Service Menu cable
YES
Are
Are the YES any cables loose
values for the Noise
on back of
as follows?
analyzer?
Values should be: NO

RBC Amph = 0
WBC Amph = 0
RBC Discr = 100 filter = 80
WBC Discr = 50 filter = 80
NO
Try plugging
analyzer into
different outlet
Is Noise test
NO
positive?
YES
Check for noisy Done

equipment and /or
try another room
YES
YES
Is Noise test Recommend trying Did line
conditioner
positive? line conditioner work?
NO
NO
Contact Service
Representative
91
TU or TL ERRORS
Re-analyze sample (system cleans and rinses

the orifice automatically when error is generated)
All highlighted areas of flowchart NO

TU/TL flag? DONE
are to be performed by trained in-
house technician ONLY.
YES
Perform a Prime, then
DONE
a background count
NO
Re-analyze TU/TL flag?

TU/TL flag?
sample
NO
YES
YES
Perform Orifice Clean

in Maintenance menu
Perform
NO
background count
Check tubing to MPA, re- Remove front cover, YES NO

see instruction in TU/TL flag? DONE
attach if necessary
manual
Check Perform heated

for blockage in NO detergent procedure, Run 2 Prime cycles
followed by a
MPA. Is there a using detergent from
background count
blockage? 6-month cleaning kit
YES
Remove right-side Check tubing to
YES
Perform MPA TU/TL flag? cover see instruction measuring chambers,
blockage removal in manual. re-attach if necessary.
procedure
NO
Is
DONE NO liquid level above
orifice in measuring
chambers?
YES
1. Perform Valve Check NO Is there Check tubing to metering

2. Contact Service and give any liquid in help columns, re-attach if
Valve Check results pump? necessary.
YES
Contact Service
Representative
92
Art no 1504154 Apr 2006

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SECTION 1: SECURITE jeNSTRUCTIONS ....................................................................................................... 5

SECTION 2: JeNSTALLATION ...................................................................................................................... dix

SECTION 3: GENERALITES OPERÇU .......................................................................................................... 17

SECTION 4: INSTRUMENT Sise .................................................................................................................... 22

SECTION 5: SAMPLE UNENALYSE............................................................................................................. 31

SECTION 6: QUALITÉ CONTRÔLE (QC) ET BLOOD CONTRÔLE MEMORY ............................................. 44

SECTION 7: CALIBRATION ......................................................................................................................... 49

SECTION 9: PARAMETER FLAGS ................................................................................................................ 60

SECTION 10: TECHNOLOGIE ..................................................................................................................... 66

SECTION 11: SPÉCIFICATIONS ................................................................................................................... 69

SECTION 12: TÉPANNAGE ......................................................................................................................... 73

UNENNEXE UNE ..................................................................................................................................... 85

Swelab Alfa analyseur d'hématologie en 3 parties produites par Boule

Numéro de série Le numéro de série est situé à l'arrière de l'instrument.

Une version de logiciel

Spécifications Les exigences de l'opérateur suivantes doivent être remplies avant

Accessoires en Accessoires et consommables listes sont disponibles auprès de votre

Détails du Boule Medical AB

Numéro de téléphone: +46 8 744 77 00

Normes EN591: 2001

Date d'Emission Avril 2006 Article n °: 1504154

Cette section décrit les caractéristiques de sécurité et les avertissements liés à

Contenu Cette section aborde les sujets suivants:

Sujet voir la page

1.1 Utilisation prévue

Le Swelab Alfa est un analyseur d'hématologie automatique destiné à être in

L'opérateur doit avoir des compétences de laboratoire de base et être au

La Boule intègre des fonctions de sécurité au sein de l'appareil afin de protéger

Afin d'assurer la sécurité de l'opérateur et l'instrument suivez les

Comme il n'y a aucune garantie de l'absence du VIH, l'hépatite B ou C ou

 Protection des travailleurs laboratoire à partir des maladies infectieuses

Procédure d'urgence 1.4

1.5 Les signes d'avertissement dans le manuel

Indique les procédures de fonctionnement qui

Indique les procédures de fonctionnement qui

Insiste procédures de fonctionnement qui

Les signes sur l'équipement

Figure 1.3 Figure 1.4

Figure 1.5 Figure 1.6

Contenu Cette section aborde les sujets suivants:

Contrôle visuel Cochez la case pour les dommages matériels. Si immédiatement

Les procédures suivantes doivent être suivies à la lettre. Boule

Installation /  utilisation à l'intérieur

Utilisation de l'instrument dans un environnement au-dessus de 32 ° C

La description Toutes les connexions sont situées sur le panneau arrière de

Nombre Partie Une fonction

Risque de choc électrique.

Manipulation de Si les transitoires à haute tension sont attendus sur l'alimentation

Risque de choc électrique.

En cas de Symptôme Solution

Avant Pour exécuter l'instrument, la fréquence et de la tension principale doit

De liaison Insérez le câble d'alimentation dans l'entrée principale d'alimentation de

2,5 Connexion de l'imprimante

La description L'imprimante est connectée à l'arrière de l'appareil avec le câble d'imprimante.

Compatible HP-PCL, IBM Proprinter

2.6 Connexion, réactifs et changement Amorçage

réactif hémolytique et isotonique Diluent, ci-après dénommé Lyse et le

Déchets Connecter le tube d'échappement (noir) à l'analyseur. Placer l'autre