COOK Medical K-MAR-5200 User manual

M E D I C A L
M E D I C A L
Manufacturer
WILLIAM A. COOK AUSTR ALIA PTY. LTD.
95 Brandl Street, Brisbane Technology Park, Eight Mile Plains, Brisbane
QLD 4113, AUSTRALIA
EC Representative
COOK IREL AND LTD.
O’Halloran Road, National Technology Park, Limerick, IRELAND
M E D I C A L
ASPIRATION UNIT
ASPIRATION UNIT
M E D I C A L
K-MAR-5200 Vacuum Pump
User Manual
Please familiarise yourself with the safety instructions before using the device.
This device may only be used by physicians and medical assistants with the appropriate technical qualification.
© COOK 2018 IFU-MA R52-7
K-MAR-5200 Instructions for Use

K-MAR-5200 Instructions for Use
Language Index
Section
English .....................................................................................................................................................................................................
Kapitola
Česky ....................................................................................................................................................................................................................................
K-MAR-5200 Vakuová pumpa – Uživatelská příručka
Než začnete toto zařízení používat, prostudujte si prosím bezpečnostní pokyny.
Toto zařízení smějí používat pouze lékaři a zdravotničtí pracovníci s odpovídající technickou kvalifikací. Afsnit
Dansk....................................................................................................................................................................................................................................
K-MAR-5200 Vakuumpumpe – Brugervejledning
Du bedes gøre dig bekendt med sikkerhedsanvisningerne, inden enheden tages i brug.
Denne enhed må kun anvendes af læger og sygeplejepersonale med de rette tekniske kvalifikationer. Abschnitt
Deutsch ...............................................................................................................................................................................................................................
K-MAR-5200 Vakuumpumpe – Benutzerhandbuch
Vor der Anwendung des Geräts bitte die Sicherheitsanweisungen lesen.
Dieses Gerät darf nur von Ärzten und medizinischen Assistenten mit angemessener technischer Qualifikation verwendet werden. Apartado
Español................................................................................................................................................................................................................................
K-MAR-5200 Bomba de vacío – Manual del usuario
Familiarícese con las instrucciones de seguridad antes de utilizar el dispositivo.
Este dispositivo sólo pueden utilizarlo médicos y personal de enfermería con la cualificación técnica adecuada. Chapitre
Français ...............................................................................................................................................................................................................................
K-MAR-5200 Pompe à vide – Manuel d’utilisation
L’utilisateur doit se familiariser aux directives de sécurité avant d’utiliser l’appareil.
L’utilisation de cet appareil est réservée aux médecins et au personnel médical ayant les compétences techniques appropriées. Ενότητα
Ελληνικά..............................................................................................................................................................................................................................
K-MAR-5200 Αντλία κενού – Εγχειρίδιο χρήσης
Παρακαλούμε εξοικειωθείτε με τις οδηγίες ασφαλείας πριν τη χρήση της συσκευής.
Αυτή η συσκευή μπορεί να χρησιμοποιηθεί μόνο από ιατρούς ή από βοηθούς ιατρών οι οποίοι διαθέτουν την κατάλληλη τεχνική εκπαίδευση. Sezione
Italiano.................................................................................................................................................................................................................................
K-MAR-5200 Pompa di aspirazione – Manuale d’uso
Prima di usare il dispositivo leggere con attenzione le istruzioni di sicurezza.
Il presente dispositivo deve essere usato esclusivamente da medici e assistenti medici in possesso delle qualifiche appropriate. Gedeelte
Nederlands ........................................................................................................................................................................................................................
K-MAR-5200 Vacuümpomp – Gebruikshandleiding
Vóór gebruik van dit instrument dient u zich vertrouwd te maken met de veiligheidsinstructies.
Dit instrument mag uitsluitend worden gebruikt door artsen en medisch personeel met de juiste technische kwalificatie. Rozdział
Polski....................................................................................................................................................................................................................................
K-MAR-5200 Pompa próżniowa – Podręcznik użytkownika
Przed użyciem tego urządzenia należy zapoznać się z instrukcjami dotyczącymi bezpieczeństwa.
Niniejszego urządzenia mogą używać tylko lekarze i personel medyczny posiadający odpowiednie kwalifikacje techniczne. Secção
Português...........................................................................................................................................................................................................................
K-MAR-5200 Bomba de vácuo – Manual do utilizador
Antes de utilizar este dispositivo, familiarize-se com as instruções de segurança.
Este dispositivo apenas pode ser utilizado por médicos e auxiliares com a formação técnica apropriada. Раздел
Русский...............................................................................................................................................................................................................................
Вакуумный насос K-MAR-5200 – Руководство по эксплуатации
Перед применением устройства изучите инструкции по технике безопасности.
Данное устройство может применяться исключительно врачами и помощниками врача с соответствующей технической квалификацией. Časť
Slovenčina..........................................................................................................................................................................................................................
K-MAR-5200 Vákuová pumpa – Príručka používateľa
Pred použitím prístroja sa oboznámte sbezpečnostnými pokynmi.
Tento prístroj môžu používať iba lekári a zdravotníci s príslušnou technickou kvalifikáciou. Luku
Suomi ...................................................................................................................................................................................................................................
K-MAR-5200 Imupumppu – Käyttöopas
Perehdy turvaohjeisiin ennen laitteen käyttöä.
Laitetta saavat käyttää vain sellaiset lääkärit ja avustajat, joilla on asianmukainen tekninen asiantuntemus. Avsnitt
Svenska ...............................................................................................................................................................................................................................
K-MAR-5200 Vakuumpump – Användarhandbok
Gör dig förtrogen med säkerhetsinstruktionerna innan apparaten används.
Endast läkare och sjukvårdspersonal med lämpliga tekniska kvalifikationer får använda denna apparat. Bölüm
Türkçe ..................................................................................................................................................................................................................................
K-MAR-5200 Vakum Pompası – Kullanıcı El Kitabı
Lütfen cihazı kullanmadan önce güvenlik talimatını öğrenin.
Bu cihaz sadece uygun teknik vasıflara sahip doktorlar ve tıbbi yardımcılar tarafından kullanılabilir.
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1-1
K-MAR-5200 Instructions for Use English
Copyright
This manual contains information that is subject to copyright. All rights reserved. This manual should not be
photocopied, duplicated on microfilm or otherwise copied or distributed, completely or in part, without the
approval of William A. Cook Australia Pty. Ltd.
Some of the parts and equipment referred to in this manual bear registered trademarks but are not identified as
such. It should therefore not be assumed that the absence of the trademark indicates that any given designation is
not subject to trademark protection.
Users of William A. Cook Australia Pty. Ltd. products should not hesitate to contact us if there are any unclear points
or ambiguities in this manual.
This symbol indicates that this product may not be treated as municipal waste. Please ensure that this product
is properly disposed of as inappropriate waste handling of this product may cause potential hazards to the
environment and human health. For more detailed information about disposal of this product, please contact your
local city office or Cook Medical Representative.
Cook fulfills its legal obligations with regards to WEEE andWaste Packaging compliance through our own takeback
initiatives and through national takeback schemes.
Please see https://www.cookmedical.com/about/sustainability-environmental-practices/waste-electrical-
electronic-equipment-directive/ for details on how to properly recycle WEEE or waste packaging in your country.
© COOK 2018
Document No: IFU-MAR52-7
Service address:
Please refer to your local Cook Medical distributor for details of your nearest authorised service agent.
WARNING:
READ THIS MANUAL.
Please familiarise yourself with the
contents of the manual before using
the device. Failure to comply with these
instructions may result in damage to
device, device contents, and/or patient
or user injury. This device should only
be used by qualified personnel.
WARNING:
ELECTRIC SHOCK HAZARD.
The equipment is to be used only with
electrical systems complying with all
IEC, CEC and NEC requirements.
WARNING:
Any adjustment, modification or
repairs to the equipment should be
carried out by persons authorised to
perform them.
Disposal of this product must be
undertaken with regard to the WEEE
directive (2002/96/EC).
General Information
1

1-2
K-MAR-5200 Instructions for Use English
Table of Contents
1
EXPLANATION OF PICTOGRAMS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
HOW TO USE THIS MANUAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Warnings and Important Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Manual Structure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1. SAFETY INSTRUCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2. ABOUT THE KMAR5200 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.1 Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.1.1 Intended users and use environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.2 Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.3 Device Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.4 Precautions for Device Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
3. INSTALLATION AND SETUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
3.1 Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
3.2 You Need to Supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
3.3 Front of the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.4 Rear of the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.5 Supply Voltage Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.6 Electromagnetic Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.7 Device Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.8 Connection to the Foot Pedal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.9 Vacuum Line and Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.10 Activating the Device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.11 Vacuum Setting Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.12 Set Display Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.13 Foot Pedal Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.13.1 Non-Latching Foot Pedal Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.13.2 Latching Foot Pedal Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.13.3 Set Foot Pedal Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.14 Boost Touch-Pad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.15 Chime Volume Adjustment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.16 Pre-Operation Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4. INSTALLATION AND SETUP CHECKLIST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5. OPERATION OF THE DEVICE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
5.1 Before the Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
5.2 Calibration of Flow Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
5.3 During the Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
5.4 Clearing Blockages in the Aspiration Line/Needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
5.5 After the Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
6. SERVICE AND MAINTENANCE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
6.1 Cleaning the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
6.2 Biannual Functionality Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
6.2.1 Functionality Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
6.3 Inspection by an Authorised Service Agent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
6.4 Return Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
7. DISPOSABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
8. TECHNICAL DATA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
9. TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
10. LIMITED WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
10.1 Liability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
10.2 Life of Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

1-3
K-MAR-5200 Instructions for Use English
How to use this Manual
The following pictograms appear on the Vacuum Pump and the Disposable Vacuum
Line with Hydrophobic Filter (K-DVLF-240)
Before connection, read the manual!
Refer to IFU – Mandatory
Standby/On
Increase Vacuum Set-Point
Decrease Vacuum Set-Point
Boost Vacuum
Patient Tube Connection
Foot Pedal Connection
Symbol for type B equipment
CE – Approval Marking
UL – Approval Marking
Dispose of in accordance with
WEEE directive (2002/96/EC)
Manufacturer
EC REP
US REP
Explanation of Pictograms
Warnings and Important Notes
Throughout these Instructions for Use, blocks of text may be accompanied by a pictogram and/or printed in
bold type. These instructions point out special service procedures or precautions that must be followed to avoid
damaging the device. These blocks are WARNINGS and IMPORTANT NOTES and they are used as follows:
WARNING: The personal safety of the patient may be involved. Disregarding this information could result
in injury to the operator, device or the contents!
WARNING: Biological hazard
WARNING: Electric shock hazard
WARNING: Explosion hazard
IMPORTANT NOTE: This provides special information that facilitates maintenance or clarifies important
instructions. Please pay particular attention to the Safety Instructions (see §1).
Manual Structure
This manual has a table of contents (page 2) to help you find section titles quickly. There is a troubleshooting guide
on page 17 to help you to trouble shoot problems.
EC Representative
Catalogue Code
Serial Number
Degree of enclosure protection from
solid objects and liquids
Do not reuse
Do not use if packaging is damaged
Keep away from sunlight
Keep dry
Batch code
Date of Manufacture
Use-by Date
Note (1): Symbols are on sterile Disposable Vacuum Line
with Hydrophobic Filter (K-DVLF-240) packaging
only.
EC REP
US REP
REF
SN
REF
SN
IP41
(1)
(1)
1

1-4
K-MAR-5200 Instructions for Use English
This manual describes the operation and intended use of the Vacuum Pump and the disposables.
It is essential to use this document to familiarise yourself with the functions and the operation of theVacuum Pump
before use.
Failure to follow these instructions can result in serious injury to the patient or the operating team and can lead to
damage or breakdown of the device and disposables.
This manual does not provide a detailed description of operation technologies, nor is it suitable for introducing
a beginner to this operating technique. Only physicians and medical assistants under the direction of a physician
with the appropriate technical qualification may use this device and disposables.
In case the Vacuum Pump fails during an operation, a replacement device and replacement disposables should be
kept within reach so that the operation may be completed.
Always work with the one-way hydrophobic filter between the collection receptacle and the Vacuum Pump to
prevent body fluids from entering the device.
Never use the Vacuum Pump if there is any indication that the tube, the filter or the device is contaminated. Do not
allow any further use of the device. Immediately notify your authorised service agent to have the device assessed.
The manufacturer has the right to refuse to carry out repairs if the products it receives are contaminated.
Always monitor the aspiration vacuum level. An excessive vacuum can lead to damage of the oocyte or other body
tissue.
There is evidence in the published literature suggesting that the use of higher vacuum aspiration pressures greater
than -300 mmHg (-40 kPa) can lead to the potential for decreased oocyte quality and, consequently, decreased
development and fertilisation potential. For oocyte aspiration, only use the highest vacuum aspiration pressure
necessary to achieve the required flow rate for the size aspiration needle being used.The boost should only be used
to clear blockages or obstructions in the aspiration line or aspiration needle when the needle is outside the patient.
The Pre-Operation Test (see §3.16) must be performed prior to each operation.
If a Vacuum Pump defect is suspected or confirmed, stop using the device until an authorised service agent has
checked it.
Internal circuitry is energised whenever theVacuum Pump is connected to mains power irrespective of whether the
device is on or in standby. Always disconnect the device from mains power before cord replacement, or cleaning.
Should any power cord or plug associated with the device become cracked, frayed, broken or damaged it must be
replaced immediately.
To reduce the risk of electric shock, do not remove covers. Refer servicing to an authorised service agent.
Protect the Vacuum Pump from being splashed by liquid. Should any liquid enter the device, discontinue use
immediately.
Please refer all servicing to the manufacturer’s authorised service agent.
Do not use in an area where flammable gases are present.
For your own safety, only use original disposables (see §7).
IMPORTANT NOTE:
Replacement device and disposables.
WARNING: Monitor the vacuum.
WARNING: Use only original
disposables.
WARNING: Not suitable for use
in an MRI environment
2.1 Intended Use
The K–MAR–5200 is a vacuum pump intended for the aspiration of body fluids and cells; in particular oocyte aspiration.
2.1.1 Intended users and use environment
The K-MAR-5200 device is intended to be used by obstetrician-gynaecologists and nursing staff who have received
specialised training in the field of obstetrics and gynecology. Service personnel may install the K-MAR-5200
Vacuum Pump and will routinely service the device.
The K-MAR-5200 Vacuum Pump is intended to be used in a sterile environment, such as an operation theatre, day
surgery theatre or fertility clinic.
2.2 Contraindications
There are no known contraindications for these devices.
2.3 Device Description
The Vacuum Pump is designed to maintain a vacuum accurately at a user specified setting with a range of
-10 mmHg to -500 mmHg when configured to display mmHg and a range of -1.0 kPa to -67.0 kPa when configured
to display kPa. In either case, the device will maintain the vacuum within ±5 mmHg (0.7 kPa).
The device can also boost the vacuum to -500 mmHg (or -67.0 kPa in kPa display mode) from any setting.
The Disposable Vacuum Line and Filter (K-DVLF-240) consists of a one-way hydrophobic filter and 240 cm long
low volume vacuum line. The Disposable Vacuum Line and Filter is used to connect ovum aspiration needles to
the Cook Vacuum Pump to prevent contamination of the unit. It is supplied sterile in peel-open packages and is
intended for single-use.
2.4 Precautions for Device Use
In the event of any electrical or mechanical fault during use or entry of fluid into the Vacuum Pump, cease use of
the device until it has been checked by an authorised service agent.
2. About the K-MAR-5200
1. Safety Instructions
1

1-5
K-MAR-5200 Instructions for Use English
An installation and set-up checklist has been included at the end of this section (see §4). This may be used to help
ensure correct preparation.
3.1 Unpacking
Items supplied
Please find the following items supplied:
1. User Manual
2. Vacuum Pump
3. Disposable Vacuum Line with Hydrophobic Filter (K-DVLF-240)
4. Foot Pedal
5. Power Cord
Check all items immediately upon receipt to make sure the contents are complete and that nothing is damaged.
The manufacturer will only honour claims for compensation which are forwarded immediately to the sales
representative or the authorised service agent.
Remove all items from plastic covers except the Disposable Vacuum Line with Hydrophobic Filter (item 3) which
needs to be handled under sterile conditions.
3.2 You Need to Supply
The following items are not supplied:
• Test Tube Heater and test tubes.
• Aspiration Fluid.
• A source of sterile distilled water.
IMPORTANT NOTE: It is
important to retain packaging for
future use. (Refer to §6.4 - Return
Procedure)
IMPORTANT NOTE: Items
required that you need to supply are
listed here.
2
5
4
3
1
3. Installation and Set-up
1

1-6
K-MAR-5200 Instructions for Use English
3.3 Front of the Device
1. Standby Indicator Indicates the powered on state, Green = Active, Orange = Standby.
2. Standby Touch-Pad Toggles the device between Active and Standby State.
3. Vacuum Display Displays the measured vacuum.
4. Vacuum Adjust Indicators Indicates Set-Point adjustment.
5. Vacuum Adjust Touch-Pad Decrease, Press to decrease the Vacuum Set-Point.
6. Vacuum Adjust Touch-Pad Increase, Press to increase the Vacuum Set-Point.
7. Boost Touch-Pad Press to boost the vacuum to -500 mmHg (-67 kPa).
8. Boost Indicator Indicates the Boost Function is active.
9. mmHg Indicator Indicates that the display will show the vacuum in mmHg.
10. kPa Indicator Indicates that the display will show the vacuum in kPa.
11. Patient Tube Connection Barb fitting for connection to the Vacuum Line and Filter.
12. Vacuum Supplied Indicator Indicates that vacuum is being supplied.
3.4 Rear of the Device
1. Power Cord Mount Used to hold the Power Cord when the device is not in use.
2. Mains Power Inlet Connect the appropriate Power Cord to this point.
3. Foot Pedal Connection Connect the Foot Pedal to this point.
4. Release Tab Release button for Foot Pedal Connection and disconnection.
3
44
567
8
9
10
11
12
1
2
3
4
1
1
2
1

1-7
K-MAR-5200 Instructions for Use English
3.5 Supply Voltage Selection
The Vacuum Pump can operate on the voltage range 100 – 240 VAC, 50 – 60 Hz. No fuse selection is required.
If the voltage is changed, it may be necessary to replace the Power Cord to an appropriately rated Power Cord.
Ensure that the correct Power Cord is connected.
3.6 Electromagnetic Compatibility
The Vacuum Pump is designed to provide a reliable controlled source of vacuum. It has been tested and found to
comply with the electromagnetic compatibility (EMC) limits for medical devices as specified by IEC 60601-1-2:2014.
These limits are designed to provide reasonable protection against harmful interference in a typical medical
installation.
Medical electrical equipment requires special precautions regarding EMC and must be installed and operated
according to these instructions. It is possible that high levels of radiated or conducted radio-frequency
electromagnetic interference (EMI) from portable and mobile RF communications equipment or other strong
or nearby radio-frequency sources could result in performance disruption of the Vacuum Pump. Evidence of
disruption may include erratic readings, equipment ceasing to operate, or other incorrect functioning. If this occurs
cease using the Vacuum Pump and contact your Cook authorised service agent.
Refer to the tables in Section 8 of this manual for guidance on electromagnetic emissions, electromagnetic
immunity, and recommended separation distance between portable and mobile RF communications equipment
and the Vacuum Pump.
3.7 Device Placement
The Vacuum Pump should be placed on a level secure surface, away from heaters, coolers, air-conditioning outlets,
mists, splashes and exposure to direct sunlight. It must not be placed in the presence of flammable gases.
The ambient temperature should be between +5°C and +35°C for the Vacuum Pump to function correctly. Position
the vacuum pump such that quick and easy disconnection of the power supply plug is not impeded.
3.8 Connection to the Foot Pedal
• Connect the Foot Pedal to the Foot Pedal Connection on the rear of the Vacuum Pump.
• The connection must snap into place with an audible click.
• Release the plug by pressing on the sides of the Foot Pedal Connection.
3.9 Vacuum Line and Filter
The Vacuum Pump uses a Disposable Vacuum Line with Hydrophobic Filter (re-order code K-DVLF-240).
To prepare and install:
• Connect the silicone tube attached to the filter to the Patient Tube Connection on the Vacuum Pump.
• Connect the luer fitting of the Disposable Vacuum Line to the vacuum supply luer fitting of the needle set.
• Connect a Syringe to the Flushing Line of the needle set (if required).
Note: This diagram indicates a Cook K-OPSD needle set.
The set up is complete and now ready for use.
WARNING: ELECTRIC SHOCK
HAZARD. Determine if the available
voltage corresponds to your device.
Connecting to the wrong voltage
will cause the Vacuum Pump to
malfunction or may permanently
damage the device!
The Power Cord must be equipped with
a safety plug. Use the enclosed Power
Cord for the connection between the
power plug and the device socket!
WITHIN THE U.S.A – Use only a listed
detachable Power Cord, type SJT,
minimum 18AWGx30, 3 conductors,
one end configured for NEMA 5-15,
other end for IEC320/CEE22!
To avoid the risk of electric shock this
equipment must only be connected to
a supply mains with a protective earth!
WARNING: EXPLOSION
HAZARD. Do not use the Vacuum Pump
in the presence of flammable gases!
WARNING: ELECTRIC SHOCK
HAZARD. Do not immerse the Vacuum
Pump!
WARNING: The Vacuum Pump
should not be used adjacent to or
stacked with other equipment. If
adjacent or stacked use is necessary,
the device should be monitored
to verify normal operation in the
configuration in which it will be used.
IMPORTANT NOTE: Use of cables
other than those specified or provided
by the manufacturer of this equipment
could result in increased electromagnetic
emissions or decreased electromagnetic
immunity of this equipment and result in
improper operation.
IMPORTANT NOTE: The
Disposable Vacuum Line and
Hydrophobic Filter (K-DVLF-240) has
been designed and tested to handle
the full vacuum range of the device.
Other vacuum lines may not be able to
withstand the full vacuum range.
WARNING: BIOLOGICAL
HAZARD. Always use the
Disposable Vacuum Line with
Hydrophobic Filter (K-DVLF-240). Never
use the device if there is any indication
that the tubing, the filter or the
Vacuum Pump is contaminated.
If the Vacuum Pump is suspected to be
contaminated, do not allow further use
of the device and immediately notify
your authorised service agent to have
the device assessed. The manufacturer
has the right to refuse to carry out
repairs if the products it receives are
contaminated.
The Disposable Vacuum Line with
Hydrophobic Filter attached to the
Vacuum Pump are for single patient
use only and must not be re-used
or resterilised. Re-use of this device
may result in cross-contamination
which may lead to the transmission
of infectious diseases. Re-sterilisation
of this device may compromise the
structural integrity of the device and
cause product failure. Once used, this
product is considered as infectious and
should be disposed of according to local
policy for disposal of biohazard waste.
3
4
5
6
7
1
2
1. Vacuum Pump
2. Disposable
Vacuum Line with
Hydrophobic Filter
3. Aspiration Line
4. Flushing Line
5. Double Lumen Needle
6. Syringe
7. Test Tube
1

1-8
K-MAR-5200 Instructions for Use English
3.10 Activating the Device
• Connect the Power Cord to the Power Inlet. The Standby Indicator should light up.
• The Vacuum Pump will either be in the standby mode or active mode depending on the last state the device was
in when mains power was disconnected.
• If the Vacuum Pump is in standby, press the Standby Touch-Pad to put the device into an active state.
3.11 Vacuum Setting Adjustment
• Press and hold the appropriate Adjust VacuumTouch-Pad.
• The vacuum will adjust in 1 mmHg or 0.1 kPa steps depending on the Display Units Setting.
• The selected value appears in the Vacuum Display.
• When the desired vacuum is reached release the Touch-Pad.
3.12 Set Display Units
The measurement units that the Vacuum Pump can display are mmHg and kPa. This setting is indicated by either
the mmHg Indicator being lit or the kPa Indicator being lit.
The factory setting is mmHg.
To change this setting:
1. Ensure that the device is in standby mode by using the Standby Touch-Pad.
2. Press Adjust Vacuum Touch-Pad Increase once, the Vacuum Display will flash up either:
Indicates mmHg Mode
Indicates kPa Mode
3. Press Adjust Vacuum Touch-Pad Increase again to toggle between mmHg mode and kPa mode.
4. Once the desired setting is achieved, switch the device into active mode.
5. The appropriate indicator should now be lit up.
6. The device should be displaying in the appropriate units.
3.13 Foot Pedal Function
The Vacuum Pump has two Foot Pedal settings, Latching and Non–Latching.
The factory setting is Non–Latching.
To determine the setting of the device depress the Foot Pedal and observe the behaviour of the device.
3.13.1 Non-Latching Foot Pedal Function
• Press and hold the Foot Pedal.
• The vacuum is applied and a chime sounds every few seconds until the Foot Pedal is released.
• Release the Foot Pedal.
• The vacuum is disconnected and the suction stops.
3.13.2 Latching Foot Pedal Function
• Press and release the Foot Pedal.
• The vacuum is applied and a chime sounds every few seconds.
• Press and release the Foot Pedal.
• The vacuum is disconnected and the suction stops.
WARNING: ELECTRIC SHOCK
HAZARD. Internal circuitry is energised
whenever the Vacuum Pump is
connected to mains power irrespective
of whether the device is on or in
standby.
1

1-9
K-MAR-5200 Instructions for Use English
3.13.3 Set Foot Pedal Function
To change the setting.
1. Ensure that the Vacuum Pump is in standby mode by using the Standby Touch-Pad.
2. Press the following sequence of Touch-Pads on the front panel to enter set Foot Pedal Function mode where
Adjust Vacuum Touch-Pads are , and Boost Touch-Pad is .
The Vacuum Display should now show either:
Indicates Latching Mode
Indicates Non-Latching Mode
If neither of these are displayed, repeat steps 1 & 2.
3. Press Adjust Vacuum Touch-Pad Decrease to toggle between Latching and Non-Latching mode.
4. Switch the device into active mode using the Standby Touch-Pad to exit the procedure.
5. To test that the Foot Pedal Function has been set, depress the Foot Pedal and the device should behave
accordingly.
3.14 Boost Touch-Pad
With a Disposable Vacuum Line with Hydrophobic Filter (K-DVLF-240), test tube, and needle set attached:
• Activate the Foot Pedal.
• The Vacuum Supplied Indicator lights up.
• Press and hold the Boost Touch-Pad , the Boost Indicator lights up.
• The device will reach a maximum vacuum of -500 mmHg (-67.0 kPa). A small overshoot may occur up to -530 mmHg
• Release the Boost Touch-Pad
• The Vacuum Display should reach the pre-selected value within ±5 mmHg.
3.15 Chime Volume Adjustment
1. Ensure that the Vacuum Pump is in standby mode by using the Standby Touch-Pad.
2. The Boost Touch-Pad can now be used to adjust the volume.
3. Each touch of the Boost Touch-Pad adjusts the volume in a sequence of 4 steps from minimum volume to
maximum volume.
The steps are displayed on the Vacuum Display with each touch of the Boost Touch-Pad.
No Volume
Minimum Volume
Medium Volume
Maximum Volume
4. You can now set the volume to suit your preference.
IMPORTANT NOTE: This
keystroke must be entered correctly to
change the Foot Pedal Function.
If the Vacuum display does not indicate
Latching or Non-Latching Mode, retry
the sequence.
IMPORTANT NOTE: The boost
vacuum may not reach -500mmHg
when testing with large gauge needle
sets due to lower flow resistance.
1

1-10
K-MAR-5200 Instructions for Use English
3.16 Pre-Operation Test
• Connect the Foot Pedal and the DisposableVacuum Line with Hydrophobic Filter (K-DVLF-240) to the Vacuum Pump.
• Switch the device on.
• Ensure that the device is set to display in mmHg mode (see § 3.12).
• Use the Vacuum Adjust Touch-Pads to select a vacuum between -120 and -170 mmHg.
• Activate the Foot Pedal. The Vacuum Supplied Indicator lights up. The chime sounds.
• The Vacuum Display may momentarily decrease (e.g from -170 to -160 mmHg). The Pump Motor may then be
heard to accelerate and bring the vacuum level back to the set level, within ±5 mmHg.
• Close the Vacuum Line by kinking, press and hold the Boost Touch-Pad.
• The device should achieve and display a vacuum of -500 mmHg. Note the vacuum is likely to overshoot and may
reach -530 mmHg.
• Release the Boost Touch-Pad and the Vacuum Line.
• Deactivate the Foot Pedal.
• The Vacuum Display should reach the pre-selected value within ±5 mmHg.
The Pre-OperationTest is now successfully completed and theVacuum Pump is ready for use in the operating room.
WARNING: ELECTRIC SHOCK
HAZARD. Internal circuitry is energised
whenever the Vacuum Pump is
connected to mains power irrespective
of whether the device is on or in
standby.
IMPORTANT NOTE: It is
recommended that the Vacuum Pump
be given a pre-operation test before
each operation.
IMPORTANT NOTE: If the
vacuum value is not reached or if the
value begins to decrease again, then
there is a leak. First check the
Disposable Vacuum Line with
Hydrophobic Filter.
IMPORTANT NOTE: If you
should find or suspect deficiencies
in the Vacuum Pump during the
described function control, the device
must not be used until the authorised
service agent has repaired it.
Never use the Vacuum Pump if there
are obvious deficiencies, especially
involving the power plugs or the power
supply connection cables.
Arrange for repair by an authorised
service agent.
Check the following:
T All items have been supplied.
T The packaging has been safely stored for future use.
T All non-sterile items have been removed from plastic covers.
T The Power Cord is correct for your region.
T The Vacuum Pump has been placed in a suitable location.
T The Vacuum Pump has undergone a Pre-Operation Test.
T The Disposable Vacuum Line with Hydrophobic Filter have been connected.
T The Foot Pedal has been connected.
T The Vacuum Pump has been activated.
T The Vacuum Display has been set to the desired units.
T The vacuum has been adjusted to the desired value.
T The Foot Pedal Function has been set to the desired setting.
4. Installation and Set-up Checklist
1

1-11
K-MAR-5200 Instructions for Use English
IMPORTANT NOTE: To ensure
patient safety, the Pre–Operation Test
(see §3.16) must be performed prior to
each use.
WARNING: BIOLOGICAL
HAZARD. Always use the
Disposable Vacuum Line with
Hydrophobic Filter (K-DVLF-240). Never
use the device if there is any indication
that the tubing, the filter or the
Vacuum Pump is contaminated.
If the Vacuum Pump is suspected to be
contaminated, do not allow further use
of the device and immediately notify
your authorised service agent to have
the device assessed. The manufacturer
has the right to refuse to carry out
repairs if the products it receives are
contaminated.
The Disposable Vacuum Line with
Hydrophobic Filter attached to the
Vacuum Pump are for single patient
use only and must not be re-used
or resterilised. Re-use of this device
may result in cross-contamination
which may lead to the transmission
of infectious diseases. Re-sterilisation
of this device may compromise the
structural integrity of the device and
cause product failure. Once used, this
product is considered as infectious and
should be disposed of according to local
policy for disposal of biohazard waste.
WARNING: Always monitor the
aspiration vacuum level. An excessive
vacuum can lead to damage of the
oocyte or other body tissue. See
vacuum warning on page 4.
IMPORTANT NOTE: Operational
Note.
This section provides general information about the use of the Vacuum Pump. Only the physician can evaluate the
clinical factors involved with each patient and determine if the use of this device is indicated. The physician must
decide on the specific technique and procedure that will accomplish the desired clinical effect.
5.1 Before the Operation
1. Ensure the Vacuum Pump is correctly set up as described in §3 including correct set up of the Disposable
Vacuum Line with Hydrophobic Filter (see §3.9) and Foot Pedal (see §3.8 & §3.13).
2. Ensure the device has undergone a Pre-Operation Test (see §3.16).
3. Use the Adjust Vacuum Touch-Pads to select the desired vacuum (see §5.2).
5.2 Calibration of Flow Rates
The first step in IVF is to obtain good quality oocytes. Calibrating the correct flow rate is the key to retrieving the
maximum number of oocytes in optimal condition. The rate of flow through an aspiration needle and tubing is
dependent upon many variables, such as: the differential height between the needle tip and the collection test
tube, the inner diameter of the needle, total length of the system and vacuum pressure according to Poiseuille’s
Law. To ensure an optimal recovery rate with minimal damage to the oocytecumulus complex and zona pellucida,
flow rates of 20-25 mL/min are recommended. Calibration can be checked by aspirating water through the
aspiration needle and adjusting the vacuum pressure to give the correct flow rate. A flow rate of 20-25 mL/min
equates to 24 to 30 seconds to aspirate 10 mL of water.
The vacuum pressure used with a specific gauge and/or type of ovum pick-up needle is at the discretion of the
clinician performing the procedure.
5.3 During the Operation
1. Insert the aspiration cannula into the follicle under ultrasound vision.
2. Activate the Foot Pedal to aspirate follicular fluid.
3. Deactivate the Foot Pedal when the follicle is empty.
4. The oocyte and follicular fluid are in the collection receptacle.
5.4 Clearing Blockages in the Aspiration Line/Needle
The vacuum pressure can be boosted to clear blockages in the ovum aspiration needle by activating the boost
button on the front panel of the unit. The boost should only be used to clear blockages or obstructions in the
aspiration line or aspiration needle when the needle is outside the patient.
5.5 After the Operation
1. Use the Standby Touch-Pad to place the Vacuum Pump in standby mode.
2. Remove the Disposable Vacuum Line with Hydrophobic Filter, Power Cord and Foot Pedal.
5. Operation of the Device
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K-MAR-5200 Instructions for Use English
To preserve the Vacuum Pump and ensure its proper functioning, proper service, maintenance and storage must
be provided for. To protect the patient from infection, all disposables that come into contact with human tissue (eg.
test tubes and tubing) must be sterile. Disposables must be discarded after each patient use.
6.1 Cleaning the Device
After each use of the Vacuum Pump, turn off the device and disconnect the device from mains power.
Using an aqueous 70% alcohol (eg. ethanol or isopropyl) solution, moisten a cloth and wipe all external surfaces of
the device. Prevent any fluid from entering the device.
Do not use a 100% alcohol solution to clean the device, this may cause damage to the front surface.
6.2 Biannual Functionality Testing
In order to preserve the Vacuum Pump and maintain its safety, regular inspections are necessary for early detection
of possible malfunctions.
Regulations stipulate that the user or a qualified technician must regularly test the device to assess its functionality
and electrical safety. These tests must be performed on a biannual basis.
6.2.1 Functionality Test
1. Vacuum Pump under test.
2. Manometer compatible 0 to -1000 mBar.
1. The basic function test is intended to check the Foot Pedal and the vacuum.
2. Ensure that the Vacuum Pump is set to display in mmHg mode (see § 3.12).
3. Connect the Foot Pedal and switch the Vacuum Pump on.
4. Set the vacuum to -200 mmHg.
5. Activate the Foot Pedal Function.
6. TheVacuum Motor and Chime should be audible (refer to §3.15 if no chime) and theVacuum Supplied Indicator
should light up.
7. Deactivate the Foot Pedal Function.
8. Connect a silicone tube and a manometer with vacuum measurement capability to the Patient Tube
Connection.
9. Activate the Foot Pedal Function.
10. The manometer should show a vacuum of -267 mBar ±7 mBar.
11. Press and hold the Boost Touch–Pad.
12. The Vacuum Pump should achieve and display a vacuum of -500 ±5 mmHg. Note there may be a small
overshoot (up to -530 mmHg). Check the manometer reading corresponds to the Vacuum Pump display
±7 mBar.
13. Release the Boost Touch–Pad.
14. Deactivate the Foot Pedal Function. The basic function test is completed.
If the Vacuum Display is not correct the Vacuum Pump should be serviced by an authorised service agent.
IMPORTANT NOTE: To
guarantee safe operation, it is
necessary to carry out proper care and
maintenance of the Vacuum Pump and
disposables. Regular checks to confirm
correct functioning of the device are
recommended! New and repaired
products must be prepared and tested
according to the manual instructions
before you use them.
WARNING: Do not sterilise the
Vacuum Pump!
WARNING: ELECTRIC SHOCK
HAZARD. Do not immerse the Vacuum
Pump!
IMPORTANT NOTE: This
functionality test must be performed
every six months.
Conversion Note:
mmHg kPa mBar
1 0,13332 1,3332
5 0,7 7
198 26,4 264
200 26,7 267
202 26,9 269
500 66,7 667
IMPORTANT NOTE: If the
vacuum value is not reached or
if the value begins to decrease
again, then there is a leak. Check
the Disposable Vacuum Line with
Hydrophobic Filter.
WARNING: If you should
find or suspect deficiencies in the
Vacuum Pump during the described
function control, the device must
not be used until it has been
repaired by the authorised service
agent.
Never use the Vacuum Pump if there
are obvious deficiencies, especially
involving the power plugs or the
power supply connection cables.
Arrange for repair by an authorised
service agent.
6. Service and Maintenance
12
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K-MAR-5200 Instructions for Use English
6.3 Inspection by an Authorised Service Agent
Inspections at least once a year For ongoing operational safety of the device, an authorised service
agent must maintain the Vacuum Pump annually as per SMA30001. The
service agent will assess the operational functionality of the vacuum
system.
Authorised service agents All services such as alterations, repairs, calibrations etc., may only be
performed by the manufacturer or by service agents who are authorised
by the manufacturer as per SMA30001.
Liability The manufacturer is free from all liability for the operational safety of the
Vacuum Pump if the device has been wilfully opened and unauthorised
persons have performed repairs or alterations on it during the warranty
period.
Certification The device owner will receive a signed certificate from the service agent
for all inspections or repairs. This certificate states the type and scope
of the services rendered, the service date and the name of the service
company.
Technical documentation If the manufacturer provides technical documentation, this does not
authorise the user to perform repairs, adjustments or alterations to the
Vacuum Pump or disposables.
6.4 Return Procedure
All devices or disposables that are returned must be prepared as described below for the protection of the service
agent and for safety during transportation.
1. Clean as detailed in §6.1.
2. Seal in a plastic bag and seal within a second plastic bag.
3. Place in the original packaging.
4. Enclose the following information:
• Owner’s name
• Owner’s address
• Model type
• Serial number of the equipment (see identification plate)
• Description of the damage or fault.
The manufacturer has the right to refuse to carry out repairs if the products it receives are contaminated.
WARNING: No user serviceable
parts inside!
WARNING: BIOLOGICAL
HAZARD. The returned product
must be clearly marked with a
contamination warning and should
be sealed in a plastic bag and sealed
within a second plastic bag!
When shipping the Vacuum Pump
ensure that any connected Disposable
Vacuum Line with Hydrophobic Filter is
removed prior to transport!
IMPORTANT NOTE: When
returning goods, use the original
packaging. The manufacturer does not
take responsibility for damage that has
occurred during transportation if the
damage was caused by inadequate
transport packaging.
IMPORTANT NOTE: For optimal
functioning of the Vacuum Pump, use
only original disposables.
The Disposable Vacuum Line with
Hydrophobic Filter has been designed
and tested to handle the full vacuum
range of the Vacuum Pump.
Other vacuum lines may not be able to
withstand the full vacuum range.
The Disposable Vacuum Line with
Hydrophobic Filter (K-DVLF-240) is a
single use device.
Order No. Description
K-DVLF-240 Disposable Vacuum Line with Hydrophobic Filter.
Consists of a 240 cm low volume aspiration line and a one way hydrophobic filter.
7. Disposables
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K-MAR-5200 Instructions for Use English
8. Technical Data
Classication according to IEC 60601-1
Type of protection against electric shock: Class I equipment
Degree of protection against electric shock: Type B
Degree of protection against harmful ingress of solids and water: IP41
Specications
Power Supply: 100 - 240 VAC
Frequency: 50 - 60 Hz
Maximum current: 500 mA (115 VAC)
250 mA (240 VAC)
Maximum power consumption: 60 VA
Environmental operating conditions: +5°C to +35°C
10% to 75% RH
700 hPa to 1060 hPa
Storage and transport directions: +5°C to +40°C
10% to 75% RH
Manufactured and tested to the following standards: IEC 60601-1: 1988 + A1: 1991 + A2: 1995
IEC 60601-1: 2005 + A1: 2012(E)
IEC 60601-1-2: 2014
ISO 10079-1: 2015
VACUUM PUMP WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH:
ANSI/AAMI ES60601-1(2005 + C1: 09 + A2: 10),
CAN/CSA-C22.2 No. 60601-1(2008), E363262
Performance class: High Vacuum / Low Flow (ISO 10079-1)
Dimensions: 200 mm wide x 100 mm high x 350 mm deep
Weight: 3.2 kg (7.1 lb)
Vacuum Ranges: -10 mmHg to -500 mmHg in 1 mmHg increments.
-1.0 kPa to -67.0 kPa in 0.1 kPa increments.
Vacuum Range Accuracy: ±5 mmHg (±0.7 kPa)
Guidance and manufacturer’s declaration – electromagnetic emissions
The Vacuum Pump is intended for use in the electromagnetic environment specified below. The customer or the end user of the Vacuum Pump should assure
that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment Guidance
RF emissions
CISPR 11
Group 1 The Vacuum Pump uses RF energy only for its internal function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
The Vacuum Pump is suitable for use in all establishments, including domestic establishments and those
directly connected to the public low voltage power supply network that supplies buildings used for
domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
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K-MAR-5200 Instructions for Use English
Guidance and manufacturer’s declaration – electromagnetic immunity
The Vacuum Pump is intended for use in the electromagnetic environment specified below. The customer or the end user of the Vacuum Pump should assure
that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic
material, the relative humidity should be at least 30%.
Electrical fast
transient
(EFT)
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 2 kV for power
supply lines
Not applicable for
input/output lines
Mains power quality should be that of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV line-to-line
± 2 kV line-to-ground
± 1 kV line-to-line
± 2 kV line-to-ground
Mains power quality should be that of a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
0% UTfor 0.5 cycle at
0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
0% UTfor 0.5 cycle at
0°, 45°, 90°, 135°, 180°,
225°, 270° and 315° Mains power quality should be that of a typical commercial or hospital
environment. If the user of the Vacuum Pump requires continued operation during
power mains interruptions, it is recommended that the Vacuum Pump be powered
from an uninterruptible power supply or a battery.
0% UTfor 1 cycle
and
70% for 0.5 seconds
0% UTfor 1 cycle and
70% for 0.5 seconds
0% UT for 5 seconds 0% UT for 5 seconds
Power frequency
(50/60Hz) magnetic
field IEC 61000-4-8
30 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical
location in a typical commercial or hospital environment.
Conducted RF
IEC 61000-4-6
3Vrms
0.15 to 80MHz
6Vrms in ISM bands
Between 0.15MHz and
80MHzc
80% AM at 1kHz
6Vrms
80% AM at 1kHz
Portable and mobile RF communications equipment should be used no closer
to any part of the Vacuum Pump, including cables, than the recommended
separation distance calculated from the equation applicable to the frequency of
the transmitter.
Recommend separation distance
d = 0.6 √P
Radiated RF
IEC 61000-4-3
3V/m
80MHz to 2.7GHz
80% AM at 1kHz
3V/m
80MHz to 2.7GHz
80% AM at 1kHz
Recommend separation distance
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.7 GHz
where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic
site surveyashould be less than the compliance level in each frequency rangeb
Interference may occur in the vicinity of equipment marked with the following
symbol:
Proximity fields
from RF wireless
communications
equipment
IEC 61000-4-3
Refer to table Refer to table Refer to table for recommended minimum separation distance
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects
and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and
FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Vacuum Pump is used
exceeds the applicable RF compliance level above, the Vacuum Pump should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the Vacuum Pump.
bOver the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m.
cThe ISM (industrial. scientific and medical) bands between 0.15MHz and 80MHz are 6.765MHz to 6.795MHz; 13.553MHz to 13.567MHz; 26.957MHz to
27.283MHz; and 40.66MHz to 40.70MHz. The amateur radio bands between 0.15MHz and 80MHz are 1.8MHz to 2.0MHz; 3.5MHz to 4.0MHz; 5.3MHz to
5.4MHz; 7.0MHz to 7.3MHz; 10.1MHz to 10.15MHz; 14MHz to 14.2MHz, 18.07MHz to 18.17MHz; 21.0MHz to 21.4MHz; 24.89MHz to 24.99MHz; 28.0MHz to
29.7MHz; and 50.0 MHz to 54.0MHz.
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K-MAR-5200 Instructions for Use English
Recommended separation distance between portable and mobile RF communications equipment and the Vacuum Pump
The Vacuum Pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of
the Vacuum Pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the Vacuum Pump as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power
of transmitter
(W)
Separation distance according to frequency of transmitter
(m)
150 kHz to 80 MHz
(d = 1.2 √P)
80 MHz to 800 MHz
(d = 1.2 √P)
800 MHz to 2.5 GHz
(d = 2.3 √P)
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects,
and people
Proximity fields from RF wireless communication equipment
Test frequency
(MHz)
Banda
(MHz)
ServiceaModulationbMaximum
power
(W)
Distance
(m)
Immunity test
level
(V/m)
Minimum
separation distance
(m)
385 360-390 TETRA 400
Pulse
modulationb
18 Hz
1.8 0.3 27 0.3
450 430-470 GMRS 460
FRS 460
FMC
±5 kHz deviation
1 kHz sine
2 0.3 28 0.3
710
704-787 LTE Band 13,17
Pulse
modulationb
217 Hz
0.2 0.3 9 0.3745
780
810
800-960
GSM 800/900
TETRA 800
iDEN 820
CDMA 850
LTE Band 5
Pulse
modulationb
217 Hz
2 0.3 28 0.3870
930
1720
1700-1990
GSM 1800
CDMA 1900
DECT
LTE Band 1, 3,
4, 25; UMTS
Pulse
modulationb
217 Hz
2 0.3 28 0.31845
1970
2450 2400-2570
Bluetooth
WLAN
802.11 b/g/n RFID
2450
LTE Band 7
Pulse
modulationb
217 Hz
2 0.3 28 0.3
5240
5100-5800 WLAN 802.11
a/n
Pulse
modulationb
217 Hz
0.2 0.3 9 0.35500
5785
Note: if necessary to achieve the IMMUNITY test level, the distance between the transiting antenna and the ME equipment or ME system may be reduced to
1m. The 1m test distance is permitted by IEC 61000-4-3.
aFor some services, only the uplink frequencies are included.
bThe carrier shall be modulated using a 50% duty cycle square wave signal.
cAs an alternative to FM modulation, 50% pulse modulation at 18Hz may be used because while it does not represent actual modulation, it would be worst case.
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K-MAR-5200 Instructions for Use English
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9. Troubleshooting
IMPORTANT NOTE: Should any errors persist, contact your COOK distributor.
Error and Alarm Indicator Source of Error Elimination of Error
Vacuum Pump will not turn on.
Displays do not illuminate.
Power supply cord is not connected. Mains
power switch is not turned on.
The device is in standby mode.
Check the power supply connection. (Refer to
§3.10).
Check that the Standby Indicator is illuminated
orange. Press the Standby Touch-Pad. (Refer to
§3.10).
Desired aspiration vacuum is not achieved. Foot Pedal is defective.
Leak in the Vacuum Line or the Filter is wet.
Disconnect the Foot Pedal from the rear of the
device without applying pressure to the Foot Pedal
and re-connect the Foot Pedal.
Change the Vacuum Line and Filter. (Refer to §7).
Chime Volume Adjustment does not adjust. Power supply cord is not connected. Mains
power is not turned on.
The device is not in standby.
Check the power supply connection. (Refer to
§3.10).
The device is functionally active, press the Standby
Touch-Pad to place the device in standby. (Refer
to §3.15).
Vacuum Pump displays the Vacuum in wrong
units.
The Display Units setting is set to either
mmHg or kPa.
Set the Display Units setting to desired units, either
mmHg or kPa. (Refer to §3.12).
Vacuum stays on when the Foot Pedal is
depressed and released.
The Foot Pedal Function is set to Latching. Set the Foot Pedal Function to Non–Latching.
(Refer to §3.13.3).
Vacuum doesn’t stay on when Foot Pedal is
depressed and released.
The Foot Pedal Function is set to Non–
Latching.
Set the Foot Pedal Function to the Latching. (Refer
to §3.13.3).
Vacuum Pump displays an error code in the form
of ER1 to 5.
Device has an internal fault. Contact service agent.
10. Limited Warranty
COOK AUSTRALIA warrants to the purchasers of this device that at time of manufacture, the product was prepared and tested in accordance with good
manufacturing practices and guidelines specified by the Australian Therapeutic Goods Administration or relevant competent authority.
In the event of product failure under normal use, due to defects in material or workmanship, within a period of one (1) year from the date of purchase, the
product will be repaired, or at Cook’s option, replaced, at no charge. This limited warranty does not apply to products subjected to abnormal use or conditions,
improper storage, damaged by accident, misuse or abuse, improper line voltage or to products altered or serviced by anyone other than Cook Australia or its
authorised agent.
The foregoing limited warranty is exclusive and in lieu of all other warranties whether written, oral, expressed or implied. In particular, Cook Australia does not
warrant that the product is suitable for the needs of the purchaser and there are no warranties given as to merchantability or fitness for a particular purpose.
Cook Australia’s representations concerning fitness for purpose or suitability for use by any purchaser does not extend beyond those representations set out
in the Cook Australia literature that accompanies the product. Cook Australia assumes that the purchaser is experienced in the use of this device and is able to
judge from his/her own expertise the suitability or otherwise of the product for the intended use. Cook Australia conducts a technical advisory service, which
can be consulted by a purchaser or intended purchaser on an advisory basis.
After one (1) year from the date of purchase, this device will be repaired for a repair charge equal to the cost of parts, labour and transport.
Before returning a product for any reason, please contact your nearest Cook distributor for assistance and instructions.
Cook Australia reserves the right to change or discontinue this product without notice.
10.1 Liability
Because Cook Australia has no control or influence over the conditions under which this device is used, over its method of use or administration, or on handling
of the product after it leaves its possession, Cook Australia takes no responsibility for the results, use and/or performance of the product. Cook Australia expects
that use of the product will be confined to trained and expert users.
In no event will Cook Australia be liable for any direct or indirect damages including incidental, consequential or special damages, arising out of or in connection
with the use or performance of the product.
If the manufacturer provides you with technical documentation, this does not authorise you to perform repairs, adjustments or alterations on the device or
disposables.
No representative of Cook Australia and no vendor or lessor of the product is authorised to change any of the foregoing terms and conditions, and the purchaser
accepts the product subject to all terms and conditions herein, subject always to any contrary provisions which are necessarily implied by stature or law
notwithstanding the within terms and conditions.
10.2 Life of Product
The expected service life is deemed to be seven (7) years. After this time Cook Australia will no longer be responsible for this product.
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