Sartorius Sartocheck mini Operating Instructions Manual
Sartorius Sartocheck mini Operating Instructions Manual

Sartorius Sartocheck mini Operating Instructions Manual

Integrity test device
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Operating Instructions
Original Operating Instructions
Sartocheck
mini
®
Integrity Test Device
1000141355

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Summary of Contents for Sartorius Sartocheck mini

  • Page 1 Operating Instructions Original Operating Instructions Sartocheck mini ® Integrity Test Device 1000141355...
  • Page 3: Table Of Contents

    Contents Contents 1 About these Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Validity .
  • Page 4 16 Sartorius Service . . . . . . . . . . . . . . . . . . .
  • Page 5: About These Instructions

    About these Instructions About these Instructions Validity These instructions are part of the device; they must be read in full and stored. These instructions apply to the following version of the device: Device Type Sartocheck mini 26292---03 ® Target Groups These instructions are addressed to the following target groups.
  • Page 6: Symbols Used

    About these Instructions Symbols Used 1.3.1 Warnings in Operation Descriptions WARNING Denotes a hazard that may result in death or severe injury if it is not avoided. CAUTION Denotes a hazard that may result in moderate or minor injury if it is not avoided.
  • Page 7: Safety Instructions

    Only the maintenance tasks described in these instructions may be carried out. For maintenance tasks that need to be carried out by Sartorius Service, contact Sartorius Service. Sartorius recommends that any repair work, even that carried out after the end of the warranty period, is carried out by Sartorius Service or after consulting with Sartorius Service.
  • Page 8: Functionality Of The Device Parts

    Only use the original power supply unit and power supply cable. If the power supply unit or power supply cable needs to be replaced, contact Sartorius Service. Do not repair or modify the power supply unit or power supply cable.
  • Page 9: Accessories And Consumables

    — Risk of injury to persons — Damage, malfunctions, or failure of the device Only use accessories and consumables that have been approved by Sartorius for this device. Operating Instructions Sartocheck mini ®...
  • Page 10: Device Description

    Device Description Device Description Device Overview Fig. 1: Device Overview Pos . Name Description Display Graphical display that has 4 lines of text and and icon line underneath Status LEDs Show a visual identification of the test result or prompts to the next step: —...
  • Page 11: Special Buttons On The Keyboard

    Device Description Special Buttons on the Keyboard Icon | buttons Description Special functions. They are shown in the display, if required. Used to delete entries. Connections 3.3.1 Compressed Air Connections The connection is made using suitable pressure-resistant and flexible pres- sure tubes with the prescribed connection couplings and nipples.
  • Page 12: Other Connections

    Device Description 3.3.2 Other Connections Fig. 3: Connections at the back of the device Pos . Name Description [Valve] For directing any harmful or sticky aerosols that may arise during ventila- tion to the outside. [USB] For connecting a Mini-USB. [Power] Charging socket, protected by a IP65 proof cover...
  • Page 13: Measuring Principle

    Device Description Measuring Principle During the integrity test, the device performs a very accurate pressure mea- surement. The device then determines the pressure drop, and calculates the diffusion rate from the pressure drop and the housing volume. Vol V1 Vol V1 P0+V2 Fig.
  • Page 14: Operating Design

    Operating Design Operating Design Fig. 6: Display (example) Pos . Name Description Button indicator Shows possible buttons that can be pressed next, e.g. [Start] or [↑]. Icon line Displays the relevant icons. Actions to be performed Icon Overview Icon Description Shows the battery status.
  • Page 15: General Functional Diagram And Overview

    Operating Design General Functional Diagram and Overview The diagram shows the relationship between the individual functions of the device. The main functions block contains all the functions that are neces- sary for the filter test and the management of the test results: Fig.
  • Page 16: Validating Entries And Deleting Text

    Operating Design Function Description CLEAN ? Removes dust or moisture from the pneumat- PROCEED > ↑↓ ic system. All valve combinations are sequen- tially opened and closed. Thus, all valves and tubing inside can be flushed by compressed air or water if applied at the pressure input. SERVICE ? Leaves the main functions and goes to the PROCEED...
  • Page 17: Service Functions

    Operating Design Service Functions The [SERVICE] menu contains all the functions that are necessary for spe- cial settings of the device. The default access code is “7”. The service functions should be utilized only by users who have been given instruction.
  • Page 18: Installation

    Technical Data“, page 43). Unpacking Procedure Unpack the device. Sartorius recommends keeping the original packaging to return the device appropriately, e.g., for repairs. Acclimatization When a cold device is brought into a warmer area: The temperature difference can lead to condensation from humidity in the device (moisture formation).
  • Page 19: Charging The Batteries For The First Time

    Installation Charging the Batteries for the First Time The charging procedure is temperature-controlled. This procedure will not operate at too high or low temperatures as this could damage the battery. The temperature is measured inside the filter tester near the battery pack. Requirements For a full recharge, the device must be switched off.
  • Page 20: Getting Started

    Getting Started Getting Started Turning the Device On Procedure NOTICE Equipment damage due to unsuitable surroundings! Operate the device in dry conditions (see chapter “15.3 Ambient Conditions“, page 43 ). Do not operate or store the device in damp surroundings for a long period of time.
  • Page 21: Calculating The Diffusion Rate

    Getting Started Before entering the current time, delete the displayed time with the [#] button. Enter a 4-digit time value as follows: 1135 = 11:35 or 0729 = 7:29 (hh:mm) Confirm with the [ ] button to store the new settings. Enter the current date in the same way.
  • Page 22: Programming

    Getting Started Programming Programming may be performed manually on the device, or with the assis- tance of the SartoControl mini software. Programming using SartoControl mini makes entry of model numbers and series numbers much easier, and is therefore recommended. The device checks the entered test parameters for the lowest possible limit. If the resulting pressure drop deltaP falls below a reasonable limit, a warning will be displayed.
  • Page 23 Getting Started Enter the test pressure according to the specifications of the filter used. TEST PRESSURE Use the displayed unit of pressure. The test pressure will also be used for ►120mbar > the stabilization phase. > ↑↓ Enter the stabilization period. STABILIZATION TIME ►180sec >...
  • Page 24: Configurating The Device

    Getting Started Configurating the Device The configuration function is used for individual adaptation of the device. Device functions can be set, activated, or deactivated here. This is a service function and password-protected. Procedure Start the [Configuration] function. CONFIGURATION ? PROCEED >...
  • Page 25: Process Preparation

    Process Preparation Process Preparation The device is connected with means of a flexible compressed air tube to the filter housing. Only purified and filtered compressed air to keep the valves clean must be used. WARNING Risk of injury and equipment damage due to unsuitable connection pres- sure! Use only suitable pressure proof tubes.
  • Page 26: Operation

    Operation Operation A constant ambient temperature should be maintained during diffusion tests as pressure measurement and diffusion rate are affected. Tests should not be conducted directly after the sterilization of the filter with superheat- ed steam; instead, they should only be performed after the filter housing has cooled down to prevent distorted values.
  • Page 27 Operation If the user code function is activated during device configuration, enter INPUT your [USER CODE] (your personal user ID). USER CODE 123 Update the batch number if needed. FILTER-LOT. > ↑↓ Confirming initiates the documentation of the integrity test. From this START TEST point on the test program runs automatically.
  • Page 28: Viewing Documentation Data

    Operation Viewing Documentation Data Procedure Start the [TEST RESULTS] function to select any test protocol stored in the device memory and to display the related data. Confirm with the [Start] button. Choose a test protocol using the [↑][↓] buttons. Search forward or backward for a particular test or select the most recent test with the [#] button.
  • Page 29: Changing The Paper Roll On The Printer

    Operation Changing the Paper Roll on the Printer To ensure functional safety during printing (well preserved printouts and a perfectly functioning printer), always use original thermal printer paper. Procedure Open the protective cover on the printer. Open the black shield by pressing the 2 holding points on the left and right together lightly and then lifting the shield.
  • Page 30: Cleaning And Maintenance

    Cleaning and Maintenance Cleaning and Maintenance Cleaning Requirements The process has been completed. Procedure Switch off the device. Only use suitable cleaning agents and observe the product information for the cleaning agents used (for compatability see chapter “15.8 Housing“, page 45). Wipe the housing with a slightly damp cloth.
  • Page 31: Charging The Battey

    The older the batteries are, the more the period of operation is reduced. If you notice that the period of operating of the charged battery pack is very short, replace it with a new battery pack from Sartorius. Requirements For a full recharge, the device must be switched off.
  • Page 32: Preparing The Calibration

    Cleaning and Maintenance 9.4.1 Preparing the Calibration Required equipment: Reference gauge, accuracy ± 1 mbar Requirements — The operating temperature is between 20 - 30°C. — Reference device has reached the operating temperature before the calibration can be performed (by switching it on 15 min beforehand). Procedure Setup 1 Connect the reference gauge (4) to the regulated compressed air source...
  • Page 33 Cleaning and Maintenance Setup 2 Connect the pressure regulating valve (4) to the regulated compressed air source (5). Pressure can be adjusted with the external regulator. Connect the reference gauge (1) to the filter connection [Out] (2) of the device. Fig.
  • Page 34: Carrying Out The Calibration

    Cleaning and Maintenance Setup 3 Connect the [In] connection (4) of the device to the air source (5). Connect the reference gauge (1) to the filter connection [Out] (3) of the device and a pressure vessel (2). Pressure can be adjusted with the interval valves of the device by press- ing the arrow buttons.
  • Page 35 Cleaning and Maintenance The last and the next calibration date is shown. This information is in the NEXT CALIBRATION last calibration data log and remains constant despite changes to the 05.01.2025 calibration interval configuration. > ↑↓ A few current values such as pressure and temperature are displayed. INPUT Enter the atmospheric pressure.
  • Page 36: Deleting Data From The Device Memory

    Cleaning and Maintenance Deleting Data from the Device Memory For service purposes, it might be useful to clear the device memory. NOTICE These functions can delete the device’s entire memory, including calibra- tion values, or only documentation and test programs . Deleting calibration values requires device recalibration .
  • Page 37: Faults

    — If the problem has not functions been resolved, contact Sartorius Service. The pressure sensor Contact Sartorius Service. is defective. Operating Instructions Sartocheck mini ®...
  • Page 38: Troubleshooting

    — If the problem has not functions been resolved, con- tact Sartorius Service. An empty test program Select a test program Operator has been selected. with valid test parame- ters. The test parameters are Re-enter the test param- 8.1, 26...
  • Page 39 The power supply unit is — Check control lamp in Operator defective. charger. — Replace the charger and order a replace- ment from Sartorius Service. The battery fuse is de- Contact Sartorius Service. fective Access to the service Wrong security code en-...
  • Page 40: Replacing The Battery

    Do not insert a standard, non-rechargeable battery into the device. Only use the batteries supplied by Sartorius. Unscrew the 2 screws (1) on each side of the back of the device. Remove the cover.
  • Page 41: Decommissioning

    Decommissioning Decommissioning Requirements The process has been completed. Procedure Switch off the device. Depressurize the device. Disconnect the device from the power supply and all supply systems. To do so, remove all cables and tubing. Disconnect all accessories from the device. Clean the device (see chapter “9.1 Cleaning“, page 30).
  • Page 42: Returning Device And Parts

    Disposal 13.2 Returning Device and Parts Defective devices or parts can be sent back to Sartorius. Returned devices must be clean, decontaminated, and packed properly or in their original packaging. Transport damage as well as measures for subsequent cleaning and disinfection of the device or parts by Sartorius are charged to sender.
  • Page 43: Technical Data

    Technical Data 15 Technical Data 15.1 Dimensions and Weights Unit Value Weight 3900 Dimensions (W x H x D) 315 x 150 x 280 15.2 Installation Conditions The installation site meets the requirements relating to the ambient conditions. Access to operation-relevant parts is guaranteed. Space Requirement Suitable for the dimensions of the device and the associated components.
  • Page 44: Storage Conditions

    Technical Data 15.4 Storage Conditions Unit Value Temperature range °C 0 – +40 Store it in its original packaging or the case. Dry environment 15.5 Electrical Data Unit Value Battery 10 x 1.2 V NiMH battery pack | 12 V, 3000 mAh accumulator pack with connection plug Charging time of the battery pack, typically Normal operation time with battery, typically...
  • Page 45: Pressure Range And Accuracy

    Technical Data 15.7 Pressure Range and Accuracy Unit Value Overpressure protection mbar 8000 Measurement range of pressure measurement mbar 0 – 4500 Repeat accuracy of pressure measurement at 20 °C mbar ± 4 Relative error of the pressure measurement at 20 °C >...
  • Page 46: Parameter Limits

    Charger Available upon request 16 Sartorius Service Sartorius Service is available should there be any queries regarding the device. Please visit the Sartorius website (www.sartorius.com) for information about the service addresses, services provided, or to contact a local representative. Operating Instructions Sartocheck mini ®...
  • Page 47: Conformity Documents

    Conformity Documents 17 Conformity Documents The attached documents confirm compliance of the device with the directives or standards cited. Operating Instructions Sartocheck mini ®...
  • Page 48 EN ISO 12100:2010, EN 61010-1:2010 +A1:2019+A1:2019/AC:2019 Die Person, die bevollmächtigt ist, die technischen Unterlagen zusammenzustellen: The person authorised to compile the technical file: Sartorius Lab Instruments GmbH & Co. KG International Certification Management 37070 Goettingen, Germany Sartorius Stedim Biotech GmbH...
  • Page 49 Conformity Documents Original EU-Konformitätserklärung EU Declaration of Conformity Diese Erklärung bescheinigt die Übereinstimmung mit den genannten EU-Richtlinien, ist jedoch keine Zusicherung von Eigenschaften. Bei einer mit uns nicht abgestimmten Änderung des Produktes verliert diese Erklärung ihre Gültigkeit. Die Sicherheitshinweise der zugehörigen Produktdokumentation sind zu beachten. This declaration certifies conformity with the above mentioned EU Directives, but does not guarantee product attributes.
  • Page 50 The information and figures contained in these instructions correspond to the version date specified below. Sartorius reserves the right to make changes to the technology, features, specifications and design of the equipment without notice. Masculine or feminine forms are used to facilitate legibility in these instructions and always simultaneously denote all genders.

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