Baaske MI 1005 Medical Isolator User Manual
- June 6, 2024
- Baaske
Table of Contents
Baaske MI 1005 Medical Isolator
© Baaske Medical GmbH & Co. KG. All rights reserved. Information in this document has been carefully checked for accuracy; however, no guarantee is given to the correctness of the contents. Photographs and schematic diagrams used in this document are for illustration purposes only. The actual product may vary. This document contains proprietary information protected by copyright. No part of this manual may be reproduced by any mechanical, electronic, or other means, in any form, without prior written permission of Baaske Medical.
This document is subject to change without notice.
General Safety Advice
Read this manual carefully before installing and implementing the MI 1005/MI 2005.
- The MI 1005/MI 2005 must be installed and implemented by qualified and trained personnel.
- Do not open the case of the MI 1005/MI 2005. There are no serviceable parts inside.
- Faulty or defective devices have to be exchanged and returned to the manufacturer.
- Before operating the MI 1005/MI 2005 in combination with medical devices, make sure that the manufacturer of the medical device permits the galvanic isolation of the Ethernet Signal.
Place of Installation
During installation ensure that the MI 1005/MI 2005 is protected from
penetration by moisture, high humidity and mechanical damage. It should not be
operated in areas or atmospheres with combustible gas mixtures.
The MI 1005/MI 2005 should also not be operated in close proximity to devices that emit electromagnetic radiation to avoid electromagnetically interferences like for example mobile phones. Potential interferences can be avoided by operating the MI 1005/MI 2005 outside this electromagnetic environment.
Connection and Operation
When connecting the MI 1005/MI 2005 Medical Isolator make sure that:
-
Not any telecommunication appliances, voltage supplies or similar are connected to the MI 1005/MI 2005. By doing so, both the MI 1005/MI 2005 and personnel could be harmed!
-
All connected Ethernet components comply with IEEE 802.3 or IEEE 802.3ab
(10/100/1000-BaseT, Twisted-Pair) or 802.3bz 2.5GBase-T (MI 2005) -
Tested and approved CAT 6 network cable (with appropriate test mark) is used.
Used symbols
Conformity
Your device meets the electromagnetic compatibility requirements and has been
tested to the standards specified herein.
UL (MI 1005 only) ANSI/AAMI ES60601-1:
A1:2012; C1:2009/(R)2012 and A2:2010/(R)2012, CSA CAN/CSA-C22.2 No. 60601-1:
2014
TÜV IEC 60601-1:2005/AMD1:2012/AMD2:2020 SÜD (Ed. 3.2)
EMV EN 60601-1-2:2015 (IEC 60601-1-2:2014)TÜV IEC
60601-1:2005/AMD1:2012/AMD2:2020 SÜD (Ed. 3.2)
EMV EN 60601-1-2:2015 (IEC 60601-1-2:2014) including tests according to:
(IEC 61000-4-2:2008: IEC 61000-4-3:2006 + A1:2007 + A2:2010, IEC
61000-4-4:2012, IEC 61000-4-6:2013)
EN 55032:2015
Full declarations of conformity are available on request.
Hotline +49 (0) 5741 2360270
Intended Use
The MI 1005/MI 2005 is an appliance especially developed for use in medical technology. The purpose of the MI 1005/MI 2005 is to connect, in compliance with the relevant norms for electrical safety (IEC 60601-1) and EMC (IEC 60601-1-2), a medical appliance or system equipped with a network interface to a non-medical appliance or system (Single PC or local network). Examples for the use of the MI 1005/MI 2005:
- Connection to the practice or clinic networks with the PC of a prolonged EEG system
- Connection to an analysis computer in the doctor’s or consulting room with an EMG measuring station
Installation
Only qualified and trained personnel should install the MI 1005/MI 2005. Please instruct your network systems administrator or your medicine technology department for this purpose. The installation of the MI 1005/MI 2005 is done by means of the two pluggable Ethernet Interfaces (RJ-45-sockets). To do this, plug the network connection cable into the socket of the MI 1005/MI 2005, until the lock engages with an audible ‚click’ (observe installation direction for MI 2005!). The installation of the MI 1005/MI 2005 should be done near the medical appliance/system. The safety advice in Chapter -1.2 – Connection and Operation- is to be observed!
Maintenance
For maintaining a safe technical condition, an annual inspection is recommended, which includes the following checks:
-
Examination for external damage (housing, network connections, legibility of labeling, dirt, etc.) of the MI 1005/MI 2005.
-
Examination for penetrated substances, especially liquids.
-
Function test.
-
Isolation test. The isolation resistance of the MI 1005/MI 2005 should not exceed 20 MOhm.
For testing, at both connections all data cables, as well as the screen, should always be shut down briefly. The isolation resistance should be measured between signal entry and signal exit. -
Availability and sufficiency of the docments.
Should any deficiency be established during a test, the MI 1005/MI 2005 should
not be used any longer, as the safety of the patients and the operator cannot
be guaranteed.
In case of doubt please contact your supplier or the manufacturer.
Cleaning
Use a dry or a moderately moisturized cloth to clean the MI 1005/MI 2005. It
must be noted that no fluids or moisture will penetrate into the device.
Potential Risk and Errors
Not any Risk or Errors are expected when the MI 1005/MI 2005 is being operated in compliance with the instructions in this manual. The fault / error rate of the MI 1005/MI 2005 is lower than 1:100000.
Technical Specifications MI 1005
| Mark of origin (Manufacturer) | Baaske Medical GmbH & Co. KG |
|---|---|
| Type | MI 1005 |
| Operating Mode | Continious Operation |
Environmental Conditions
During Operation| Temperature| -10°C up to +85°C
Rel. Humidity| 10% – 90% (not condensing)
Air pressure| 700 hPa up to 1060 hPa
During Storage / Transport| Temperature| -10°C up to +85°C
Rel. Humidity| 10% – 95%(not condensing)
Air pressure| 500 hPa up to 1060 hPa
Protection grade according EN 60529| IPX0
Dimensions (LDH)| 65 x 29 x 23 mm
Weight| ~ 30 g
Operation Voltage Max.| 300 V AC / 400 V DC
Isolation Voltage AC 50Hz 60s| 5,0 kV
Reinforced Isolation| according to IEC 60601-1
---|---
Supported Network protocols and transmission speed| 10 Mbit/s 10Base-T
(IEEE802.3 Cl.14)
100 Mbit/s 100Base-Tx (IEEE802.3 Cl.25)
1000 Mbit/s 1000Base-T (IEEE802.3 Cl.25)
Interfaces| 2 x RJ45 port
Material| UL94V-0 complying materi- als RoHs compliant
MTBF (Mean time to failure)| 0,21 x 10^8 (1 Error in
21 000 000 hours)
Product Classification| Passive ethernet isolation device, Isolation rate DI
(300V AC / 400V DC) tested with 5kV AC
Means of Protection| 2 MOPP
Isolation Diagram|
Mark of origin (Manufacturer)| Baaske Medical GmbH & Co. KG
---|---
Type| MI 2005
Operating Mode| Continious Operation
Environmental Conditions
During Operation| Temperature| -10°C up to +85°C
Rel. Humidity| 10% – 90% (not condensing)
Air pressure| 700 hPa up to 1060 hPa
During Storage / Transport| Temperature| -10°C up to +85°C
Rel. Humidity| 10% – 95% (not condensing)
Air pressure| 500 hPa up to 1060 hPa
Protection grade according EN 60529| IPX0
Dimensions (LDH)| 65 x 29 x 23 mm
Weight| ~ 30 g
Operation Voltage Max.| 300 V AC / 400 V DC
Isolation Voltage AC 50Hz 60s| 5,0 kV
Reinforced Isolation| according to IEC 60601-1
---|---
Supported Network protocols and transmission speed| 10 Mbit/s 10Base-T
(IEEE802.3 Cl.14)
100 Mbit/s 100Base-Tx (IEEE802.3 Cl.25)
1000 Mbit/s 1000Base-T (IEEE802.3 Cl.25)
2500 Mbit/s 2.5GBase-T (IEEE802.3bz)
Interfaces| 2 x RJ45 port
Material| UL94V-0 complying materi- als RoHs compliant
MTBF (Mean time to failure)| 0,21 x 10^8 (1 Error in
21 000 000 hours)
Product Classification| Passive ethernet isolation device, Isolation rate DI
(300V AC / 400V DC) tested with 5kV AC
Means of Protection| 2 MOPP
Isolation Diagram| 
Scope of Delivery
- MI 1005/MI 2005 Network isolator
- User Manual
- connection cable CAT6 0,25m grey PIMF (optional)
Check the delivery contents and request any missing items from your retailer immediately.
Warranty Regulations
The manufacturer of the device is only responsible for damage in terms of safety, reliability and performance if repairs are carried out by persons authorized by him and the device is used in accordance with the instructions for use.
The terms and conditions of Baaske Medical GmbH & Co. KG, valid at the time of
delivery of the product, are available under the Internet address:
www.baaske-medical.com/general-terms-and-conditions
Manufacturer Contact
For queries and questions please contact:
Manufacturer:
Baaske Medical GmbH & Co. KG
Bacmeisterstr. 3
32312 Lübbecke
Germany
Phone: +49 5741 236027 – 0
Fax: +49 5741 236027 – 99
E-mail: sales@baaske-medical.com
Web: www.baaske-medical.com
References
- medical.com is for sale | www.brandforce.com
- VON MANNSTEIN CONCEPT DESIGN
- Medical network isolators | PCs, Computer | Keyboards and mice | Baaske Medical
- General Terms and Conditions | Baaske Medical
- PCs | Netzwerkisolatoren | Medizin Tastaturen | Baaske Medical
- AGB | Baaske Medical
- General Terms and Conditions | Baaske Medical