steute MKF 2 2S/2S SW2.4LE-MED GP212 User manual

Produktname: MKF 2 2S/2S SW2.4LE-MED GP212
Material-Nr.: 1423899
Created on: 31.03.2020 Revision of data sheet: E D022557
Page
1 / 3
steute Technologies
GmbH & Co. KG
Brückenstraße 91
32584 Löhne, Germany
Phone [phone]
Fax [phone]
[e-mail]
www.steute.com
Specification
 baseplate GP212 in light grey RAL 7035 with additional bush button B7R(2PW) in black
 Black pedals
 receptacle-ODU 6pol (GX1F1C-P06MFD0-0001) with hinged cover
 LED indication for battery status and transmission
 Lithium-ion battery
 steute wireless (SW2.4LE)
Technical Data
Applied standards
IEC 60601-1 (Basic Safety)
IEC 60601-1-2
IEC 60601-2-2
IEC 60601-2-22/ only applicable with protection handle
IEC 60601-2-43
IEC 60529 (Degrees of protection)
Note: see CSA certificate for corresponding revision level.
Existing certifications CSA
Enclosure
Shockproof thermoplastic , self
-
extinguishing / Light grey RAL 7035
Pedal
Shockproof thermoplastic,
self
-
extinguishing / black, RAL 9005
Pedal enclosure
shockproof thermoplastic, self
-
extinguishing / black
Actuator
1
x B7,
black
Degree of protection
IPX8 (1m / 35 Min.) according to DIN EN 60529
Contact element/material Pedals: Reed/rhodium
Actuator: microswitch/ gold-plated
Rated operating voltage (Ue) Rechargeable battery: Li-Ion 3,6V / 2900mAh
Charging voltage 9 VDC – max. 600 mA
Mechanical lifetime
> 1 Mill. operations

Produktname: MKF 2 2S/2S SW2.4LE-MED GP212
Material-Nr.: 1423899
Created on: 31.03.2020 Revision of data sheet: E D022557
Page
2 / 3
steute Technologies
GmbH & Co. KG
Brückenstraße 91
32584 Löhne, Germany
Phone [phone]
Fax [phone]
[e-mail]
www.steute.com
Radio specifications
Performance
Distance 10 m -30 m (with internal antenna, depends on spatial conditions and the surrounding)
Output rating 3 dBm (max. 7 dBm optional)
Input sensitivity -93 dBm
Antenna Internal antenna with U.FL-plug
Radio technology
Frequency range 2402 to 2480 MHz
Chanel spacing 2 MHz
Modulation GFSK, adaptive frequency hopping of 40 channels
Applied radio standards
Europe EN 300 328 V2.1.1, EN 301 489-1 V2.2.0, EN 301 489-17 V3.2.0
Transmitter and radio
module
registration
USA , Part 15C , single Modular, Identifier: XK5-SW24LE
Canada RSS-247 Issue 1, Identifier: 5158A-SW24LE
Japan ARIB STD-T66, Identifier: 204-650001
Please note the instruction manual for the SW2.4LE system (D023336) (Document on request)
Environmental conditions
Storage/Transport (without batteries) Operating Battery charging
Temperatur
e
range
-20 °C up to +60 °C 0 °C up to +45 °C 0 °C up to +40 °C
Relative humidity
10 % up to 100 % 10 % up to 100 % 10 % up to 100 %
Air
pressure
500 hPa – 1060 hPa 700 hPa – 1060 hPa 800 hPa – 1060 hPa
General notes
The foot switc
h
as a component of a medical device can be evaluated only together in the overall system of the customer. Therefore the
conformity evaluation including the classification of the overall system according to the Medial Device Directive 93/42/EEC respectively EU
Medical Device Regulation 2017/745 must be carried out at the customer. In addition, validation can also only be carried out by the customer
in the overall system.
Furthermore, the intended use and the basic functions are verifiable only in interaction with the overall system. As a result, the customer
must involve the footswitch in his risk management, his usability analysis, the verification of the electromagnetic compatibility and, if
applicable, the verification of the biocompatibility.
Please refer to the Technical Description (D031288) for Medical synthetic footswitch SW2.4LE-MED/ Powered by rechargeable battery
Maintenance/cleaning
 During cleaning, avoid wiping with a cloth under the pedal, because this may cause the springs to move out of position.
Safety instructions

Produktname: MKF 2 2S/2S SW2.4LE-MED GP212
Material-Nr.: 1423899
Created on: 31.03.2020 Revision of data sheet: E D022557
Page
3 / 3
steute Technologies
GmbH & Co. KG
Brückenstraße 91
32584 Löhne, Germany
Phone [phone]
Fax [phone]
[e-mail]
www.steute.com
Despite careful production and inspection as well as redundant design of important components, an entirely safe function cann
ot be
guaranteed at all times (in case of malfunction, for example, a switch contact can turn off incorrectly).
Risk of injury due to incorrect handling!
• The plug connections must not be subjected to mechanical loads!
•
Components, especially pedals or other actuating elements, may not be dissembled or dismembered under any
circumstances! If this
happens the products need to be send back immediately.
Errors and omissions excepted.