2. General User Information
2.1 About this user manual
This user manual provides the user with helpful information about the entire life cycle of the BactoSense and its peripheral devices. Before commissioning and using the instrument, you should be completely familiar with the user manual.
The user manual is intended for all persons who are responsible for the operation and maintenance of the instrument. This document is part of the product. It should be stored in a safe place and always be available to the user.
The most recent version of this document can be ordered from the bNovate representative in your country. A list with all bNovate representatives can be found on our website: www.bnovate.com/distribution-partners.
Additional associated product documentation can be found in the table below.
Table 2-1 Additional documentation
| 40101 | Quick Guide | Basic information needed to operate the BactoSense. |
| 40108 | Cleaning Kit User Manual | Usage of the reagent kit to decontaminate the BactoSense. |
| UM_0003 | Validation Kit User Manual | Usage of the reagent kit used to validate proper functioning of the BactoSense. |
| UM_0004 | SST Kit BactoSense PURE User Manual | Usage of the reagent kit to perform the system suitability test. |
| 50115 | CE declaration of conformity | Compliance with the underlying directives and standards. |
| 50116 | UKCA declaration of conformity | Compliance with the underlying directives and standards. |
| 50117 | CB test report | UL/CSA/FCC compliance report, also under CH-12116 on https://certificates.iecee.org |
2.2 Compliance and applied standards
The BactoSense has been designed and manufactured to meet or exceed industry- recognized standards to ensure the safety, performance, and reliability of the product.
The device meets all applicable requirements for carrying the CE mark. For more details, please refer to the separate declaration of conformity.
The device meets all applicable requirements for carrying the UKCA mark. For more details, please refer to the separate declaration of conformity.
This Class B digital apparatus meets all requirements of the Canadian Interference-Causing Equipment Regulations (CAN ICES-001 (B) / NMB-001 (B)).
This device complies with Part 15 of the FCC rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
This device is protected from total dust ingress and from low pressure water jets from any direction (IP65).
This device complies with FCC, UL/CAN/CSA-C22.2/IEC 61010-1 and JIS C 1010-1. For more details refer to the CB test report. (https://certificates.iecee.org: CH-12116).
The following standards have been applied to guarantee compliance with regulatory requirements:
APPLIED STANDARDS
Safety (General) (Heating Element) (Laser)
- IEC 61010-1:2010
- IEC 61010-1:2010/A1:2016
- CAN/CSA-C22.2 No. 61010-1 + A1
- UL 61010-1, 3rd Edition A1
- JIS C 1010-1:2019
- IEC 61010-2-010:2019
- CSA C22.2 No. 61010-2-010:19
- EN 60825-1:2014 + A11:2021
- CAN/CSA-E60825-1:15
EMC
- EN IEC 61326-1:2021
- EN 61326-1:2013, Class B, Group 1
- CISPR 11:2015/A1:2016/A2:2019
- EN 61000-3-2:2018
- EN 61000-3-3:2013/A1:2017
- EN 61000-3-11:2017
- EN 61000-3-12:2011
- EN 61000-4-2:2008
- EN 61000-4-3:2006/A1:2007/A2:2017
- EN 61000-4-4:2012
- EN 61000-4-5:2014/A1:2017
- EN 61000-4-6:2016
- EN 61000-4-8:2009
- EN 61000-4-11:2020
- EN 55011:2016/A1:2017/A2:2021/A11:2020
Ingress Protection
- IEC 60529:1989
- IEC 60529:1989/A1:1999
- IEC 60529:1989/A2:2013
- IEC 60529:1989/A2:2013/C1:2019
- EN 60529:1991/A1:2000/A2:2013
RoHS
- EN IEC 63000:2018
The BactoSense is classified as a Class 1 Laser product according to the standard IEC 60825-1:2014/A11:2021.
2.3 Safety symbols
The symbols below identify hazards and required protective equipment. Warning and Caution use the same exclamation symbol; read the title and instructions in every box.
Electric shock that may result in serious injury or death
Ignoring this notice may lead to electrical shocks and death.
Explosion that may result in serious injury or death
Ignoring this notice may cause explosions resulting in serious property damage and death.
Injury or hazards to health with long-term effects
Ignoring this warning may lead to injuries with possible long-term effects.
Ignoring this notice may cause material damage to the instrument and its peripherals.
Mandatory protective equipment
Wear the specified protective gloves when handling samples, sampling devices, cartridges or components that come into contact with samples.
2.4 Pictograms
All pictograms used in this document are explained below:
Additional information about the current topic.
The screenshot is an example of the graphical user interface and may be different on your instrument.
2.5 Intended use of the BactoSense
The intended use of the BactoSense is to measure the concentration of microorganisms in water. In particular, the instrument has been developed to count and characterise bacterial populations.
The instrument must be operated by trained technical personnel who have read and understood the content of the user manual.
2.6 Usage restrictions
Operation in explosive areas can cause explosions, which can lead to the injury or death of persons in the vicinity.
- It is not permitted to operate the instrument in explosion hazardous areas or rooms.
- It is not permitted to use the instrument with explosive sample substances.
2.7 Improper use
Improper use of the instrument can cause injuries to persons, process-related consequential damage and damage to the instrument and its peripherals. In the following cases the manufacturer cannot guarantee the protection of persons, the instrument and surrounding equipment, and therefore assumes no legal responsibility:
- The instrument is not used in the described area of application and intended use.
- The instrument is not installed, mounted, set up or transported in accordance with the user manual.
- The instrument is not operated in accordance with the user manual.
- The instrument is operated with accessory parts or consumables which bNovate Technologies SA has not specifically provided, approved or recommended.
- The instrument underwent improper changes or modifications.
- The instrument is operated outside of the specifications, in particular pressure, temperature and power.
- The instrument is operated with a different power supply unit.
- The instrument is exposed to vibrations, shocks, or other mechanical forces.