steute MKF 2 2S User manual

Produktname: MKF 2 2S/2S SW2.4LE-MED GP211
Material-Nr.: 1437458
Created on: 22.09.2022 Revision of data sheet: K D027110
Page
1 / 3
steute Technologies
GmbH & Co. KG
Brückenstraße 91
32584 Löhne, Germany
Phone [phone]
Fax [phone]
[email protected]om
www.steute.com
Specification
 baseplate GP211 with fold handle
 2 extra push button black
 batterie compartment
 position sensor
 LED indication for battery status and transmission
 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 / Pantone cool grey 1C
Pedal
Shockproof thermoplastic, self
-
extinguishing / black, RAL 9005
Pedal enclosure shockproof thermoplastic, self-extinguishing / black
Actuator 2x 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) Battery: 3xLR14 (1,5 V DC) = 4,5 V DC / batteries not included in scope of delivery
Mechanical lifetime > 1 Mill. operations
Dimension 391 x 211 x 178 mm
Weight 1,8 kg
batterie
: 3xLR14 (1,5 V DC)
=>7500-8000 mAh

Produktname: MKF 2 2S/2S SW2.4LE-MED GP211
Material-Nr.: 1437458
Created on: 22.09.2022 Revision of data sheet: K D027110
Page
2 / 3
steute Technologies
GmbH & Co. KG
Brückenstraße 91
32584 Löhne, Germany
Phone [phone]
Fax [phone]
[email protected]om
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; EN 301 489-1; EN 301 489-17; EN 62479, EN 62368-1, EN IEC 63000
Note: see EU Declaration of Conformity for corresponding revision level
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
Temperature range -20 °C up to +60 °C 0 °C up to +45 °C
Relative humidity 10 % up to 100 % 10 % up to 100 %
Air pressure 500 hPa – 1060 hPa 700 hPa – 1060 hPa
General notes
The foot switch 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 (D031289) for Medical synthetic footswitch SW2.4LE-MED/ battery-powered
Maintenance/cleaning
 During cleaning, avoid wiping with a cloth under the pedal, because this may cause the springs to move out of position.

Produktname: MKF 2 2S/2S SW2.4LE-MED GP211
Material-Nr.: 1437458
Created on: 22.09.2022 Revision of data sheet: K D027110
Page
3 / 3
steute Technologies
GmbH & Co. KG
Brückenstraße 91
32584 Löhne, Germany
Phone [phone]
Fax [phone]
[email protected]om
www.steute.com
Safety instructions
Despite careful production and inspection as well as redundant design of important components, an entirely safe function cannot be guaranteed at all
times (in case of malfunction, for example, a switch contact can turn off incorrectly, or a spring may break).
A functional test must be performed before every operation.
Risk of injury due to incorrect handling!
 The plug connections must not be subjected to mechanical loads!
 Switch off terminal before cleaning or maintenance work!
 Test functions when device is switched back on!
 Moving actuating components (e.g. carrying handle) can be a crushing hazard!
 Tripping hazard!
If components with reed contacts or hall sensors are used, strong magnetic fields can result in unwanted influences to the system. Additionally,
magnetically conducting materials are to be kept away from the direct foot switch area!
The electrical connection may only be carried out by authorized personnel.
Components, especially pedals or other actuating elements, may not be dissembled or dismembered under any circumstances! If t
his happ
ens the
products need to be sent back immediately.
Errors and omissions excepted.