SAFE SWITCHGEAR FOR COMPLEX AND CRITICAL APPLICATIONS // Medical equipment … · 2017-04-27 ·...

SAFE SWITCHGEAR FOR COMPLEX ANDCRITICAL APPLICATIONS

// Medical equipment / Catalogue

Foot-operated controls

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4 steute in Löhne 6 Development of customised foot-operated controls12 The process from the idea to the product14 We offer more than regulations demand

PRODUCTS

16 1-pedal medical foot-operated controls18 Series MKF-MED21 Series MGF-MED23 Series RF-MED24 2-pedal medical foot-operated controls26 Series MKF2-MED29 Series MGF2-MED30 3-pedal medical foot-operated controls32 Series MKF3-MED34 Series MTF3-MED36 Medical foot-operated rocker controls38 Series WF-MED40 Medical multi-function foot-operated controls42 Series MFS-MED46 Products with RF/BT-module52 Products with integrated interfaces

TYPICAL APPLICATIONS

58 Foot-operated controls for laser devices60 Foot-operated controls for high-frequency surgery62 Foot-operated controls for X-ray/MRI/CT64 Foot-operated controls for operating theatre beds/chairs66 Foot-operated controls for ophthalmology68 Foot-operated controls for dental equipment

STANDARDS AND DIRECTIVES

70 Classification according to risk classes70 The CE mark and the classifications71 Directives in Europe71 IEC 60601-1, third edition72 Decrease in risks for patients and users72 Risk analysis/risk management73 Risk analysis and/or product standard

74 Examinations, approvals, certificates

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// STEUTE IN LÖHNE. FOOT-OPERATED CONTROLS FOR MEDICAL EQUIPMENT CREATIVE AND PRACTICABLE SOLUTIONS ON AN INTERNATIONAL BASISESTABLISHED SET, STANDARDS AND DIRECTIVES.

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steute, a middle-size company located in Löhne/ Westphalia, wasfounded in 1961 and has an excellent reputation as a manufac-turer of electrotechnical products for machinery, apparatus and plantengineering.

Today steute with about 160 employees develops and manufac-tures a large program of switchgears for complex and critical applica-tions. steute’s industrial range includes various designs of control devices, like foot or pull-wire switches, as well as safety switchgear.Ex switchgear are applied where flammable atmospheres can occur.In these applications extremely high safety and quality standards areapplied. Our program for medical equipment comprises hand- andfoot-operated control devices.

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This catalogue informs about our extensive program of foot-operated control devices for medical equipment. Foot controls fromsteute can be found in hospitals, dentists’ and doctors’ surgeries, labo-ratories, operating theatres and rehabilitation facilities all over theworld. They conform with the relevant standards and are manufac-tured according to the highest quality standards – whether standard devices that are mainly assembled in our automated mass-production or customised, complex switching systems that are produced in low quantities with a high degree of manual work.

steute adheres conscientiously to the virtue of a middle-size manufacturing company: Short term paths, decisions made quickly – and the customers are our focus. Their success is the life ofthe company.

For all business and production processes the highest qualitystandards are required, therefore steute has three different qualitymanagement systems: 1. DIN EN ISO 9001 for the production of thecomplete product portfolio. 2. DIN EN ISO 13485 for devices for medicalequipment. 3. Directive 94/9/EC (ATEX) for Ex switchgear.

The devices for medical equipment have to meet high require-ments concerning safety, function, ergonomics and reliability. The legislator has already been meeting these demands on a nationalbasis since 1986 – by legislative regulations for the production andsales of medical devices (MED-GV).

Since 1995, when the Medical Device Directive came into effect(MDD), the national regulations have been harmonized in Europe.Since then new criteria regarding safety and quality of medical equip-ment have applied. These criteria are – together with the customer requests – the guideline for the medical equipment of steute Schaltgeräte GmbH & Co. KG.

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// TEN FACTORS FOR EFFICIENT COOPERATION OF DESIGN AND PRODUCTION IN CUSTOMISED SOLUTIONS FOR MEDICAL EQUIPMENT APPLICATION

CREATIVITYcan be taken for granted. Based on theirlong time experience in the developmentof customised foot-operated control devi-ces for medical equipment, our designersalso use unconventional means in order tofind the best solution.

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AT THE BEGINNINGstands the vision of what the perfect solu-tion for an individual application shouldlook like. The precise requirements arespecified together in a conversation. Onthe basis of these requirement specifica-tions our engineers then generate a basicdesign that will be presented to you.

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//4

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FLEXIBILITYbelongs to the customers’ focus for a manufacturer of customised devices. Thisis also valid for all business processes andof course for the complete production. Intimes of »trouble« we are also at your ser-vice in exceptional situations. Because weknow: We are only successful if you aresuccessful.

VIRTUALLYand with the help of modern software weare able to simulate the motion sequenceof the operation of switches. »Rapid proto-typing« and our efficient prototype con-struction generate the first prototype fast.Also for the follow-up steps, e.g. clinicaltesting, you can rely on our support.

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IN-HOUSEwork is highly rated. Thus the finish of thecast housings, for example, is done by us – on modern CNC machines. That ishow we guarantee highest quality andshort delivery times.

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PAPERWORKis a must, proving that our products conformwith the relevant standards. At your requestwe supply all the documents that you require,e.g. for the approval of medical devices for export markets.

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//7CAREis our top priority during production. Thisis valid for the mainly automated massproduction, as well as for smaller seriesthat are produced by experienced employ-ees. An extreme work process division isdeliberately avoided.

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//9SPEEDis not witchcraft for steute, but the resultof intelligent production planning and flexible manufacturing. The time from thefirst conversation to the delivery of thecomplete products is a central parameterof our efficiency.

QUESTIONS OF IDENTITYare solved very pragmatically: of coursewe deliver your foot controls according toyour corporate design. A top modern pow-der-coating system allows for the produc-tion of exceptional colour requests andcares for the perfect finishing of small series.

We offer a large standard program for medical equipment – and many more cus-tomised foot controls. Because we are ofthe opinion: In critical applications controldevices must be adapted optimally – to theenvironmental conditions, to the ergono-mics, to the design of the medical device,to the required parameters and to the operator.

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//10THE FINISHED PRODUCTis the top priority of our work. Coopera-tional thinking can be taken for granted,as well as motivation and the willingnessto roll up our sleeves in order to promote projects.

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// FROM THE IDEA TO YOUR PRODUCTA WELL-PLANNED PROCESS-OPTIMISED SYSTEMATICAL DESIGN PROCESS

If one follows the other»Good planning is half the work«: This motto is also valid for the

development and production of foot controls. We have optimised andstructured the work processes in such a way that at a minimum ofproduction time a maximum of flexibility and quality is achieved.Therefore you can expect from us a quick reaction, even if an indi-vidual solution for a complex task is requested.

w ww w w

// 1. VISION

// 2. REQUIREMENT PROFILE

// 3. RISK ANALYSIS

// 4. STUDY(3D DRAWINGS, ERGONOMIC SAMPLE, ETC.)

// 6. USA

// 5. PROTOTYPE

w

13

ww wBILITY

// 8. CLINICAL TESTING

// 7. FIRST SERIES

// 9. SERIES

w

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// WE OFFER MORE THAN THE VALIDREGULATIONS DEMAND

Everything is easyOur extensive program of foot-operated control devices for medi-

cal equipment shows our competence in this field: You can expect alot from us. And even exotic requirements cannot shock our spe-cialists.

If you think finding the optimum foot control is hard, we will con-vince you of the opposite! On pages 16 to 46 we introduce our stan-dard program that we, of course, can adapt to your customised re-quirements.

As a middle-size company with short decision paths and a flexibleproduction we also like to develop and produce your »desired switch«– in an exclusive design, with individual housing, with special operat-ing elements or safety equipment. To find out how we proceed, pleaseread pages 6 to 13.

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The CE marking per Medical Device Directive 93/42/EEC.

The GM mark: Approved medical device.

The AP mark for anaesthesia approved medical devices.

The type test per IEC 60 601.

The approval per UL 60601.

The Quality Management System per DIN EN ISO 9001/EN ISO 13485.

What can we offer you?- CE-conforming products per directive 93/42/EEC - Products per standard series IEC 60601 - Approval per UL 60601 - Protection classes up to IPX8 per IEC 60529 - Customised developments - Ergonomic samples - Longtime experience in the cooperation with manufacturers of

medical devices- Application-related know-how- Special switch inserts for low currents- Gas-proof encapsulated switching elements for AP applications - Exclusive designs- Easy-to-clean features- Special prewired cables and plug-in connectors- Different thermoplastic and aluminium enclosures- Wireless transmission technology

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1-pedal medical foot controls

// Series MKF-MEDShock-proof, glassfibre-reinforcedthermoplastic foot controlstarting on page 18// Series MGF-MEDEasy-to-clean aluminium die-cast foot controlstarting on page 21// Series RF-MEDAll-side actuation aluminium die-cast foot controlstarting on page 23

RF-MED

Features/Options -high mechanical stability-non-contact switching systems-reed contacts for small currents-digital or analogue output signals-class AP-GM (approved medical device, TÜV)-plug-in connector-pressure point-special labels-different RAL colours

Standards IEC 60601-1; UL 60601-1; IEC 60529; MPG 93/42/EEC

Pedal shock-proof thermoplastic, UL 94-V0/-V2

Protection class IP X5 per IEC 60529, up to IP X8 as optionSwitching element reed contact/micro switch/Hall sensorSwitching system 1 – 2 NO contacts/1 change-over/analogue

output 0 … 10 VDC, 0 … 20 mA, 4 … 20 mAMechanical life > 1 million operationsTermination 2 m cable, other lengths

optionally availableSwitching voltage max. 25 VAC/60 VDCSwitch-on current max. 1 A/max. 5 ASwitching power max. 30 VA/max. 1250 VASupply voltage Hall sensor 15 … 30 VDC/max. 25 mA

Features/Options -high mechanical stability-non-contact switching systems-reed contacts for small currents-digital or analogue output signals-additional push-buttons-LEDs-hinged stainless steel protective bracket -wireless signal transmission -class AP-GM (approved medical device, TÜV)-plug-in connector-pressure point-special labels-different RAL colours


Pedal shock-proof thermoplastic, UL 94-V0/-V2 Console GK-Al alloy, RAL 7035Protection class IP X5 per IEC 60529, up to IP X8 as optionSwitching element reed contact/micro switch/Hall sensorSwitching system 1 – 2 NO contacts/1 change-over/analogue


optionally availableSwitching voltage max. 25 VAC/60 VDCSwitch-on current max. 1 A/max. 5 ASwitching power max. 30 VA/max. 1250 VASupply voltage Hall sensor 15 … 30 VDC/max. 25 A

// MKF-MED

1-pedal medical foot controls// Series (M)KF-MED

18Photo shows optional accessories

// MKF-MED GP12

Photo shows optional accessories

Features/Options -high mechanical stability-non-contact switching systems-reed contacts for small currents-digital or analogue output signals-additional push-buttons-LEDs-protective bracket -class AP-GM (approved medical device, TÜV)-plug-in connector-pressure point-special labels-different RAL colours


Pedal shock-proof thermoplastic, UL 94-V0/-V2

Console GK-Al alloy, RAL 7035Protection class IP X5 per IEC 60529, up to IP X8 as optionSwitching element reed contact/micro switch/Hall sensorSwitching system 1 – 2 NO contacts/1 change-over/analogue


optionally availableSwitching voltage max. 25 VAC/60 VDCSwitch-on current max. 1 A/max. 5 ASwitching power max. 30 VA/max. 1250 VASupply voltageHall sensor 15 … 30 VDC/max. 25 mA

Features/Options -protection against unintentional actuation -high mechanical stability-non-contact switching systems-reed contacts for small currents-digital or analogue output signals-class AP-GM (approved medical device, TÜV)-plug-in connector-pressure point-special labels-different RAL colours


Pedal shock-proof thermoplastic, UL 94-V0/-V2 Protective shield steel sheet, RAL 7035Protection class IP X5 per IEC 60529, up to IP X8 as optionSwitching element reed contact/micro switch/Hall sensorSwitching system 1 – 2 NO contacts/1 change-over/analogue



// KF-MED GP11 // MKFS-MED

Photo shows optional accessories19

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Features/Options -maximum protection against unintentional actuation at minimum dimensions

-high mechanical stability-non-contact switching systems-reed contacts for small currents-digital or analogue output signals-class AP-GM (approved medical device, TÜV)-plug-in connector-pressure point-special labels-different RAL colours


Pedal shock-proof thermoplastic, UL 94-V0/-V2Protective flap stainless steel, RAL 7035Protection class IP X5 per IEC 60529, up to IP X8 as optionSwitching element reed contact/micro switch/Hall sensorSwitching system 1 – 2 NO contacts/1 change-over/analogue



// KF-MED SK11

1-pedal medical foot controls// Series (M)KF-MED

// MKF-MED SK 12

Features/Options -maximum protection against unintentional actuation at minimum dimensions

-high mechanical stability-non-contact switching systems-reed contacts for small currents-digital or analogue output signals-GM (approved medical device, TÜV)-class AP-plug-in connector-pressure point-special labels-different RAL colours

Standards IEC 60601-1; UL 60601-1; IEC 60529; MDD 93/42/EEC

Pedal shock-proof thermoplastic, UL 94-V0/-V2Protective flap shock-proof thermoplastic, RAL 7035Baseplate GD-Zn alloy, RAL 7035Protection class IP X5 per IEC 60529, up to IP X8 as optionSwitching element reed contact/micro switch/Hall sensorSwitching system 1 – 2 NO contacts/1 change-over/analogue



Features/Options -high mechanical stability-easy-to-clean-digital or analogue output signals-additional push-buttons-protective bracket-wireless signal transmission -class AP-GM (approved medical device, TÜV)-plug-in connector-pressure point-special labels-different RAL colours


Enclosure GD-Al alloy, enamel finish RAL 7035Pedal GD-Al alloy, enamel finish RAL 7035Protection class IP X5 per IEC 60529, up to IP X8 as optionSwitching element switch insert, positive break, gold contacts/

Hall sensor/potentiometerSwitching system slow action: 1 NC/1 NO contact or 2 NC/2 NO

contacts/analogue output0 … 10 VDC, 0 … 20 mA, 4 … 20 mA

Output value poti 20 Ω … 1 kΩ ±3 %; 20 Ω … 2 kΩ ±3 %; 50 Ω … 5 kΩ ±3 %; 100 Ω … 10 kΩ ±3 %;

Linearity ±0,5 %Mechanical life > 1 million operationsTermination 2 m cable, other lengths

optionally availableSwitching voltage max. 25 VAC/60 VDCSwitch-on current max. 5 ASwitching power max. 1250 VASupply voltage Hall sensor 15 … 30 VDC/max. 25 mA

// MGF-MED

// MGF-MED with bracket1-pedal medical foot controls// Series MGF-MED

Variante,Retusche,siehe Faxvon Hr.

Kutschanv. 26.10.04

// MGF-MED with push-button

// MGF-MED



Features/Options -protection against unintentional actuation -high mechanical stability-easy-to-clean-digital or analogue output signals-wireless signal transmission -class AP-GM (approved medical device, TÜV)-plug-in connector-pressure point-special labels-different RAL colours


Enclosure/Protective shield GD-Al alloy, enamel finish RAL 7035Pedal GD-Al alloy, enamel finish RAL 7035Protection class IP X5 per IEC 60529, up to IP X8 as optionSwitching element switch insert, positive break, gold contacts/

Hall sensor/potentiometerSwitching system slow action: 1 NC/1 NO contact or 2 NC/2 NO

contacts/analogue output0 … 10 VDC, 0 … 20 mA, 4 … 20 mA




// MGFS-MED

1-pedal medical foot controls// Series MGF-MED

22

// MGFS-MED

// MGFS-MED

// MGFS-MED

Features/Options -all side actuation-high mechanical stability-non-contact switching systems-reed contacts for small currents-class AP-GM (approved medical device, TÜV)-plug-in connector-special labels-different RAL colours


Switching plate GK-Al alloy, RAL 7035Enclosure GD-Al alloy, RAL 7035Protection class IP X5 per IEC 60529, up to IP X8 as optionSwitching element reed contact/micro switchSwitching system 1 – 2 NO contacts /1 change-over contactMechanical life > 1 million operationsTermination 2 m cable, other lengths

optionally availableSwitching voltage max. 25 VAC/60 VDCSwitch-on current max. 1 A/max. 5 ASwitching power max. 30 VA/max. 1250 VA

// RF-MED

1-pedal medical foot controls// Series RF-MED

// RF-MED

// RF-MED

// RF-MED

23

25

MKF 2-MED GP26


// Series MKF 2-MEDFoot control on thermoplastic/aluminium consolestarting on page 26// Series MGF 2-MEDAluminium die-cast foot control starting on page 29

Features/Options -high mechanical stability-non-contact switching systems-reed contacts for small currents-digital or analogue output signals-LEDs-protective bracket -class AP-GM (approved medical device, TÜV)-plug-in connector-pressure point-special labels-different RAL colours


Pedal shock-proof thermoplastic, UL 94-V0/-V2 Console shock-proof thermoplastic, UL 94-V0Protection class IP X5 per IEC 60529, up to IP X8 as optionSwitching element reed contact/micro switch/Hall sensorSwitching system 1 – 2 NO contacts/1 change-over/analogue



// MKF 2-MED GP25

2-pedal medical foot controls// Series MKF 2-MED


// MKF 2-MED GP25

// MKF 2-MED GP25

// MKF 2-MED GP25



Features/Options -high mechanical stability-non-contact switching systems-reed contacts for small currents-digital or analogue output signals-additional push-buttons-LEDs-protective bracket -wireless signal transmission -class AP-GM (approved medical device, TÜV)-plug-in connector-pressure point-special labels-different RAL colours










// MKF 2-MED GP23


// MKF 2-MED GP21

27



Pedal shock-proof thermoplastic, UL 94-V0/-V2 Console GD-Al alloy, RAL 7035Protection class IP X5 per IEC 60529, up to IP X8 as optionSwitching element reed contact/micro switch/Hall sensorSwitching system 1 – 2 NO contacts/1 change-over/analogue



// MKF 2-MED GP26



// MKF 2-MED GP26

// MKF 2-MED GP26



// MGF 2-MED

// MGF 2-MED

Features/Options -high mechanical stability-easy-to-clean-digital or analogue output signals-additional push-buttons-hinged stainless steel protective bracket -wireless signal transmission -class AP-GM (approved medical device, TÜV)-plug-in connector-pressure point-special labels-different RAL colours


Enclosure GD-Al alloy, enamel finish RAL 7035Pedal GD-Al alloy, enamel finish RAL 7035Protection class IP X5 per IEC 60529, up to IP X8 as optionSwitching element switch insert, positive break, gold contacts/

Hall sensor/potentiometerSwitching system slow action: 1 NC/1 NO contact or

2 NC/2 NO contacts/analogue output0 … 10 VDC, 0 … 20 mA, 4 … 20 mA




2-pedal medical foot controls// Series MGF 2-MED

// MGF 2-MED



// MGF 2-MED

// MGF 2-MED



31

MKF 3-MED GP34


// Series MKF 3-MEDFoot control on aluminium console starting on page 32// Series MTF 3-MEDFoot control in ergonomic aluminium die-cast enclosure starting on page 34






// MKF 3-MED GP34



// MKF 3-MED GP34

// MKF 3-MED GP34

// MKF 3-MED GP34






Pedal shock-proof thermoplastic, UL 94-V0/-V2 Console GD-Al alloy, RAL 7035Protection class IP X5 per IEC 60529, up to IP X8 as optionSwitching element reed contact/micro switch/Hall sensorSwitching system 1 – 2 NO contacts/1 change-over/analogue



Features/Options -high mechanical stability-non-contact switching systems-reed contacts for small currents-digital or analogue output signals-additional push-buttons-LEDs-protective bracket -wireless signal transmission -class AP-GM (approved medical device, TÜV)-plug-in connector-pressure point-special labels-different RAL colours-4- or 5-pedal type available





// MKF 3-MED GP31

33

// MKF 3-MED GP33

Photo shows optional accessories Photo shows optional accessories

Features/Options -flat design-ergonomic design-easy-to-clean-high mechanical stability-tactile switching points-reed contacts for small currents-class AP-approved medical device, TÜV-plug-in connector-special labels-different RAL colours


Enclosure GD-Al alloy, RAL 7035Actuator robust, operating theatre approved siliconProtection class IP X8 per IEC 60529Switching system reed contactSwitching element 1-2 NO contacts per actuatorMechanical life > 1 million operationsTermination 2 m cable, other lengths

optionally availableSwitching voltage max. 25 VAC/60 VDCSwitch-on current max. 1 ASwitching power max. 30 VA

// MTF 3-MED

3-pedal medical foot controls// Series MTF 3-MED

34

// MTF 3-MED


// MTF 3-MED



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PRODUCTION PROCESS COATING LINE MOUNTING FACILITY OF OUR MODERN COATING LINE

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WF-MED GP14

Medical rocker foot controls

// Series WF-MEDRocker foot control, zinc die-cast housingstarting on page 38

Features/Options -rocker switch for fast change between two functions

-high mechanical stability-non-contact switching systems-reed contacts for small currents-digital or analogue output signals-class AP-GM (approved medical device, TÜV)-plug-in connector-pressure point-special labels-different RAL colours


Pedal GD-Zn alloy, RAL 7035Enclosure shock-proof thermoplastic, UL 94-V0 Protection class IP X5 per IEC 60529, up to IP X8 as optionSwitching element reed contact/micro switch/Hall sensorSwitching system 1 – 2 NO contacts/1 change-over/analogue




-high mechanical stability-non-contact switching systems-reed contacts for small currents-digital or analogue output signals-additional push-buttons-LEDs-class AP-GM (approved medical device, TÜV)-plug-in connector-pressure point-special labels-different RAL colours


Pedal GD-Zn alloy, RAL 7035Enclosure shock-proof thermoplastic, UL 94-V0 Console GK-Al alloy, RAL 7035Protection class IP X5 per IEC 60529, up to IP X8 as optionSwitching element reed contact/micro switch/Hall sensorSwitching system 1 – 2 NO contacts/1 change-over/analogue



// WF-MED

Medical rocker foot controls// Series WF-MED

38

// WF-MED GP14


-high mechanical stability-non-contact switching systems-reed contacts for small currents-digital or analogue output signals-additional push-buttons-LEDs-protective bracket-wireless signal transmission-class AP-GM (approved medical device, TÜV)-plug-in connector-pressure point-special labels-different RAL colours


Pedal GD-Zn alloy, RAL 7035Enclosure shock-proof thermoplastic, UL 94-V0Console Al alloy, RAL 7035Protection class IP X5 per IEC 60529, up to IP X8 as optionSwitching element reed contact/micro switch/Hall sensorSwitching system 1 – 2 NO contacts/1 change-over/analogue



// WF 3-MED GP71 // WF 3-MED GP71

// WF 3-MED GP71

39

41

Medical multi-function foot controls

// Series MFS-MEDMulti-function foot control – complex, flexible and modular starting on page 42

MFS-MED GP71

Features/Options -actuating plate with joystick function-high mechanical stability-non-contact switching systems-reed contacts for small currents-digital or analogue output signals-additional push-buttons-LEDs-protective bracket-wireless signal transmission -class AP-GM (approved medical device, TÜV)-plug-in connector-pressure point-special labels-different RAL colours


Pedal shock-proof thermoplastic, UL94-V0/-V2 Console GK-Al alloy, RAL 7035Protection class IP X5 per IEC 60529, up to IP X8 as optionSwitching element reed contact/micro switch/Hall sensorSwitching system 1 – 2 NO contacts/1 change-over/analogue








// MFS-MED GP13

Medical multi-function foot controls// Series MFS-MED

42Photo shows optional accessories Photo shows optional accessories

// MKF 4-MED GP42







Features/Options -joypad with joystick function-high mechanical stability-ergonomic design-easy-to-clean-digital or analogue output signals-additional push-buttons-LEDs-protective bracket-class AP-plug-in connector-different RAL colours


Enclosure Al alloy, RAL 7035Actuator/joypad robust, operating theatre approved siliconProtection class IP X5 per IEC 60529, up to IP X8 as optionSwitching element reed contact/micro switch/inductive sensorSwitching system 1 – 2 NO contacts/analogue outputMechanical life > 1 million operationsTermination 2 m cable, other lengths


// MKF 5-MED GP51 // MFS-MED GP71


Features/Options -joypad with joystick function-high mechanical stability-ergonomic design-easy-to-clean features-horizontally and vertically adjustable pedal -digital or analogue output signals-additional push-buttons-LEDs-class AP-protective bracket with emergency-stop

function-special labels-plug-in connector-different RAL colours


Enclosure shock-proof thermoplastic, RAL 7035 Actuator/joypad robust, operating theatre approved siliconProtection class IP X5 per IEC 60529, up to IP X8 as optionSwitching element reed contact/micro switch/inductive sensorSwitching system 1 – 2 NO contact/analogue outputMechanical life > 1 million operationsTermination 2 m cable, other lengths


// MFS-MED GP72

// MFS-MED GP72 Medical multi-function foot controls// Series MFS-MED


Variante,Retusche,siehe Faxvon Hr.

Kutschanv. 26.10.04

// MFS-MED GP72



45

PRODUCTION PROCESS ASSEMBLYPreassembly foot pedal type MGF 2-MED

47

Products with RF/BT module

// Wireless foot-operated control devices Bluetooth

Why wireless?Wireless foot-operated controls are desirable for medical equip-

ment – for three reasons. Firstly cables are dangerous »obstacles«,secondly they are hard to clean and thus do not conform with thestrict hygenic requirements. Thirdly cables limit the ergonomics be-cause the operator cannot move the foot control in every desired position.

In the past steute has used different technologies for wireless signal transmission in foot-operated controls for medical equipment,also infrared and radio signals. Now a totally new chapter has beenopened: In cooperation with a university the standardised Bluetoothprotocol has been revised in such a way that it meets the high re-quirements made of medical equipment concerning safe transmission.With the new RF/BT module, which can be implemented into nearlyevery foot-operated control, signals are transmitted safely and reliably – absolutely without cables.

48

// THE NEW RF/BT MODULE NEW FREEDOM FOR MEDICAL EQUIPMENT – AND THE OPERATORS

1. The frequency band is divided up into 79 channels

Channel 1 Channel 2 Channel 3

2402 MHz 2406 MHz 2480 MHz

Frequency

Channel 4 Channel 78 Channel 79

2. Transmitter and receiver synchronously change the transmission channels.

Channel25Transmitter

Up to 1600 hops per second

Channel5

Channel40

Channel75

Channel47

Channel59

Channel11

Channel25

Channel5

Channel40

Channel75

Channel47

Channel59

Channel11

v v v vvvv

Receiver

Time

v v v v

v

vvv

Fig. 1

Fig. 2

Interference resistancesteute enables users to operate different devices in parallel, with-

out any interference. Besides numerous techniques for the automaticdetection and correction of transmission errors, Bluetooth also providesadditional safety by avoiding sources of interference using its frequencyhopping technique.

The frequency band used by Bluetooth is divided up into 79 chan-nels (Fig. 1), which can all be used for data transmission equally. Duringtransmission these channels are permanently changing (Fig. 2), so thatdata batches with interference can be retransmitted on another chan-nel (with no interference).

49

Configuration areaIf two wireless devices use the same radio technology, they can

communicate with each other and swop information. This feature,which at first sight seems extremely positive and which was the moti-vation behind the Bluetooth development, also involves a whole seriesof dangers.

Controls with wires are either firmly connected to a device or are atleast coded by a particular plug or a particular configuration as be-longing to one device series. If you take the cable away, you also losethis special device coding.

In order to ensure that transmitter and receiver definitely match,steute has included a configuration area in its RF/BT module where theorigin and functions of each different module can be individually entered (Fig. 3).

Besides classification data like manufacturer, device type and de-vice class (e.g. foot control), the module’s configuration data can also bestored. These are the number and function of digital and analogue I/Os,operational settings like alarm duration and warning delay, as well asthe baud rate of the serial interface. With these configuration data thetransmitter and the receiver can establish during the connection process whether they are compatible and whether safe operation istherefore possible.

3. Customised configuration

Classification Configuration Serial interface

v v v

Manufacturer-ID

Device-ID

Device class

Compatible device

Digitale I/O

Analogue I/O

Warning times

Alarm times Baud rate

Fig. 3

// SECURE TRANSMISSIONWITHOUT ANY CABLES

50

The peripheryAll input and output signals are handled at the edge of the board

on a 26-pin connector. With a minimum of external configuration, up to4 digital functions are possible.

Additional peripheral components can be connected via the I2Cbus. In this way, up to 14 digital and 2 analogue signals can be transmit-ted. The maximum reaction time is 50 ms.

A serial interface with adjustable transmission speed (baud rate) isalso integrated. Depending on the external configuration, asynchro-nous interfaces with cables (e.g. RS232) can be replaced by the RF/BT.The module requires a stabilised voltage of 2.9-3.4V. Peak power con-sumption is approx. 150 mA.

Initialisation procedureIn order to increase operational safety even further, steute has inte-

grated a whole series of innovative functions. To enable Bluetooth con-trols to be »connected« ad hoc to any device as with a cable, steute em-ploys a special initialisation procedure. Via an infrared path a seconddata channel is established, along which the transmitter and the recei-ver can exchange data. In addition to an individual and globally uniqueidentification number, manufacturer and configuration details are alsoexchanged. In this way any incompatibility is detected before operationcommences and can thus be effectively prevented.

SensorsWireless foot controls have no cables to tie them down to one loca-

tion. In order to rule out incorrect operation, in-house sensors perma-nently monitor the location of each control. If one is lifted off the floor,all functions are automatically blocked and a warning signal emitted. Ifthe control is not replaced within a certain period (configurable bet-ween 1 and 60 seconds), radio transmission automatically ceases.

// SAFE OPERATION BYINNOVATION

Technical data RF/BT module

Design Bluetooth qualified microprocessorsystem with an intelligent safety concept

Topology max. of 2 foot-operated controls to one receiver

Transmission Bluetooth, globally recognised and authorised radio standard

Functions max. 14 digital and 2 analogueVoltage 2.9 - 3.4 V, 150 mA Operating time approx. >10 h, depending on the

foot-operated controlPower 1 mWRange approx. 10 mResponse time < 50 msAnalogue transmission 8 Bit resolutionBaud rate 2400, 9600, 19200, 57.6k, 115k baudStandards/directives EN 60601-1, EN 60601-1-2, EN 60950,

EN 301498-1, EN 301498-17, EN 61000-3-2, EN 61000-3-3, EN 300 328-2, CE (93/42/EEC), ISO 14971, UL 1950, FCC part 15, J60950, ARIB-STD-T66

Approval for Europe, USA, Canada, Japan (other countries on request)

Safety functions - guaranteed safe parallel operation of several controls

- special initialisation procedure facilitates easy removal of defective controls

- permanent monitoring of radio path- monitoring of operational location

through position sensors- automatic disconnection of foot control

after configurable delay

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Battery operationThe wireless foot control is powered by a conventional rechargeable

battery. Depending on the size of the control, different types of rechargeable batteries can be used, facilitating different operatingtimes. In order to keep down electricity consumption, thusguaranteeing operation for as long as possible, energy-saving compo-nents were consistently employed throughout the development of themodule. With a double-pedal foot control and three 1600 mAh cells, anoperating time of approx. 10 hours could be achieved.

The way the battery is monitored can be adjusted to suit individualneeds. From a simple digital display of the battery level or themonitoring of voltage, to complex measuring procedures with auto-matic actuation of a test load, different concepts suitable for all man-ner of applications have been incorporated.

An intelligent charging procedure additionally guarantees fast andcareful charging, and thus longer battery life.

The charger used can charge all types of battery with extreme pre-cision. Even partly empty batteries can be charged; the special chargingprocedure prevents a memory effect from occurring. Once the batteryhas been fully charged, the processor automatically switches to a careful trickle charge.

Connector configurationVoltage 2.9 – 3.4 V, 150 mA- Battery level as a digital and/or analogue signal- IR transmission signal for additional signal amplifiers- Serial interface up to 19200 baud- 4 bidirectional digital signals- Position sensor- LEDs for displaying module state- I

2C bus expands port for up to

14 bidirectional digital signals2 analogue signals

I2C I2C

Connection Transmitter Connection ReceiverTransmitter Radio path Receiver

Serial data

Up to 14 digital signals

Up to 2 analogue signals

Control lamps

Battery andcharge indicator

Position sensor

Serial data

Open collectoroutput

Relay output

Analogue signals

Control lamps

Power supply

53

Products with integrated interfaces

// Foot-operated controls with USB interfacePage 54

54

Foot controls with USB interface In nearly all factories, laboratories and hospitals foot controls en-

sure that machines and devices can be operated reliably, even whenusers literally have their hands full. Originally these controls used totrigger simple switching procedures; nowadays users expect far moreand the options have become far more sophisticated. For example,steute now develops and produces foot controls with integrated tilting switches and joypads which can be used to control far morecomplex procedures.

// A TREND IN THESE APPLICATION FIELDS OF MEDICAL TECHNOLOGY IS THE DESIRE FOR SIMPLE, STANDARDISED INTERFACES

55

// USB IS STANDARD ONEACH MODERN PC

A further trend in this field of control technology is a desire for simple, standardised interfaces. For this requirement steute has already developed foot controls which can communicate with variousdevices totally without wires. Now another flexible connection optionhas been realised: foot controls can be equipped with a USB interfacetransmitting signals to conventional PCs. Up to eight digital and threeanalogue inputs can be read.

Problem-free integrationThe new interface can be integrated within nearly all the foot

controls in the steute range – even those with several switching sys-tems for different operations. If desired, steute can also extend thefunction of the USB board to incorporate additional customer-tailoredfunctions. Further interfaces can be realised on request, e.g. RS 232,RS 485 and Game Port.

The USB connection is advantageous when, for example, trans-mitted information needs to be visualised. The positioning of a pedalor a joypad can be displayed on a PC screen, for example, or the oper-ating status of various actuators can be shown on overriding visuali-sation systems.

In this way transparency is increased and operators and staff areinformed about activated device functions. This helps to avoid incor-rect functioning and/or activation – an important factor for user safe-ty. The USB interface has the added advantage of being a standardisedfeature within every state-of-the-art PC.

Available Interfaces– USB– RS 232– RS 485– Game Port– . . .

57

Typical Application Fields

// Laser devicesPage 58// High frequency surgeryPage 60// X-ray/ MRI / CTPage 62// OP-beds / chairsPage 64// OphthalmologyPage 66// Dental equipmentPage 68

Lasergeräte

58

Besides the IEC 60601-1 the IEC 60601-2-22 must also be observedfor foot-operated control devices for diagnostic and therapeuticallaser devices . This standard demands, for example, high requirementsfor mechanical stability. It requires protection against unintentionalactuation and prescribes specific actuating forces. Besides this, cer-tain protection classes – depending on the appropriate application –are determined according to IEC 60529. A mainly redundant design ofthe switching elements, as well as details concerning the cable and itsentry at the foot-operated control device, also belong to the require-ments.

// CONTROL DEVICES FOR LASER SYSTEMS


// KF-MED GP11


// Blindtext

59

// MKF-MED SK12

// MGFS-MED

// MKF-MED GP12

At work in the oper-ating theatre and forthe control of thera-peutical and diag-nostic laser devices,a non-tiring work situation is very im-portant.

// MKFS-MED


// KF-MED SK11

60

// CONTROL DEVICES FOR HIGH FREQUENCY SURGERY

For the actuation of high frequency surgery devices, foot-operatedcontrol devices are applied. The requirements for these control devicesare prescribed in EN 60601-1, as well as in EN 60601-2-2. Foot controlsfor this application field are characterised by defined requirements forthe protection class, as well as mechanical stability. Electrostatic charging must be avoided. The requirements for class AP (anaesthesiaapproved) might also be relevant. In this case the foot controls aregas-proof encapsulated (zone M). The main actuating elements are ayellow pedal (activation »cutting«) and a blue pedal (activation »co-agulating«).


// MKF 2-MED GP26


61

The HF surgery allows for gentleoperations in manyfields.

// MKF 2-MED GP25 // MGF 2-MED

// Customised solution


// MTF 3-MED


62

// CONTROL DEVICES FOR X-RAY / MRI / CT

For the application field X-ray/MRI/CT multi-function footcontrols developed especially by steute are mainly applied. In mostcases complex positioning movements must be carried out, therefore»standard« foot controls can only rarely be applied.

Observed standards are, for example, IEC 60601-1, that refers tothe general regulations for safety aspects, as well as the appropriateproduct standards, e.g. IEC 60601-2-43, considering the specific specialities of X-ray equipment.

The main features of foot controls for this application field: A defined minimum requirement for mechanical stability; defined requirements for the protection class; partly redundant design ofswitching elements; an integrated interface on request; use of multi-function elements.

View inside: BesideX-ray equipment,MRI- and CT-devicesare therefore used,that can be operatedvia steute footcontrols.

63




// MKF 3-MED GP33



64

The general requirements for control devices for operating bedsand chairs are described in the standard IEC 60601-1. As far as pub-lished, the appropriate product standards must be considered.

The main features of foot controls for this application field: A defined minimum requirement for mechanical stability; defined requirements for protection class; partly redundant design of switch-ing elements; an integrated interface on request; use of multi-function elements.

When the personnelhave got their handsfull with things todo, the patient onthe operating bedcan be broughtcomfortably into theoptimum positionusing a foot control.

// CONTROL DEVICES FOR OPERATING BEDS / CHAIRS

65

// MKF 4-MED GP42 // WF 3-MED GP35

// MKF 5-MED GP51


// CONTROL DEVICES FOR OPHTHALMOLOGY

66

In Ophthalmology absolute precision is required – also for the operation of control devices. Because doctors and operating personneloften need both hands in order to carry out operations, foot controlsare used for the operation of medical equipment. Therefore an extremely high operating safety must be secured, as well as a high degree of precision. Control devices from steute are equivalently designed – whether it comes to standard devices or customised footcontrols. The program for this application field includes among othersrocker foot controls that allow for fast change between two func-tions, foot controls with wireless signal transmission and multi-func-tion foot controls with pedal and joystick.

67

// Blindtext

// Customised solution // WF-MED GP14

Eyes are sensitive.Therefore the controldevices of equipmentfor ophthalmologymust be very sensi-tive and precise inoperation. Foot con-trols from steute areadapted accordingly.

// WF-MED



// CONTROL DEVICES FOR DENTAL APPLICATIONS

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The IEC 60601-1 describes the general safety requirements forfoot controls for dental applications. The special features of foot con-trols for these applications: Use of multi-function elements, »joypad«for adjustment of the chair position; revolution control via lever orfoot pedal; protective/carrying handle with emergency-stop function;protection class up to IP X8 for operating applications (class AP); ac-tuating elements in different variations.

The main functionsof chair and instru-ments can be con-trolled via multi-function foot con-trols from steute.

69

// Blindtext

// MFS-MED GP13 // MFS-MED GP72

Photo shows optional accessories Photo shows optional accessories

// MFS-MED GP71


// MFS-MED GP72


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The CE mark and the classification

All medical equipment has to meet certain classification regula-tions. The EC directives for medical equipment (93/42/EEC) distinguishbetween four classes (I, IIa, IIb, and III), which the medical equipmentmust be assigned to. The manufacturers are obliged to classify theirproducts according to the risk classes, class I has got the lowest andclass III the highest risk potential.

Because our foot- and hand-operated control devices for electro-medical devices also come within the purview of the Medical DeviceDirective, our medical equipment is classified accordingly.

The design engineers and product managers for medical equip-ment have adhered carefully to the standards and directives valid forour products for years. How we proceed, which standards we mustobserve and which future developments might be realised in this difficult-to-analyse field, are explained shortly and in summary in theappendix following this catalogue.

// STANDARDS AND DIRECTIVES

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w w w w

According to the MDD accessories have to be treated in the sameway as the medical devices. Accessories are objects, materials, prepa-rations like software, which are not a medical device itself, but aredestined by the manufacturer to be applied in conjunction with a medical device, in order to apply these according t0 their destinationor to support the destination determined for the medical device.

Our switchgear control medical devices – in combination with thecontrol unit connected by the customer – according to their desti-nation. They are classified as accessories and must be equipped with aCE mark according to the MDD.

The series KF-MED, for example, meets all relevant conditions thatresult from the Medical Device Directive (Directive 93/42/ EEC), thestandard IEC 60 601 and class AP. Furthermore protection classes upto IP X8 per IEC 60529 are achieved with this series.

In order to meet the high quality and safety requirements for medical equipment, we submit as a manufacturer of medical equip-ment to an additional voluntary safety examination by a competentauthority (notified body).

The safety examination contains a type test of the product on thebasis of European harmonised standards, a plausibility test of the pre-scribed conformity process for the CE mark, including the technicaldocumentation according to the EC directive and a factory inspectionwith repeated production controls.

These additional voluntary safety controls are marked on our footcontrols with the GM mark (approved medical device) placed by theTÜV.

The way to classification according to risk classes

Classification of the product

Class I Class IIa Class IIb Class III

Medical device

Fulfilment of the basic requirements

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Which directives are valid for medical control devices in Europe?

The EC directive for medical devices (MDD) or in Germany the lawfor medical devices, appendix I, name basic requirements for medicaldevices: »The products must be designed and produced, that their use… does not endanger … the safety of the patients«. So the solutions for the design and development of the products chosen by the manu-facturer must meet the basic principles of integrated safety, underconsideration of the general approved state-of-the-art. »Selecting theappropriate solutions the manufacturer must apply the followingbasic principles in the given sequence: 1. Elimination or minimisationof hazards (integration of the safety concept into the developmentand manufacturing of the product). 2. If necessary, appropriate safetymeasurements including alarm appliances against hazards thatcannot be eliminated. 3. Instruction of the operator about remaininghazards that cannot be secured by protective measures«.

The standard IEC 60601 determines the safety concepts for electrical medical devices worldwide. In the IEC 60601-1 (medical electrical devices) it is stated: 1. section 3.1: »The devices may notcause under normal conditions and at a first fault … any endangerings… «. 2. section 2.10.11 defines the conditions of the first fault: »State,where a single protective measurement inside the device has become defective ...«. 3. section 52.1 »The devices must be designed and pro-duced in such a way that even at a first fault no endangering occurs«.

The complementing standards of series IEC 60601 describe the requirements that are assigned to each device class (example: IEC60601-2-22 for laser devices and IEC 60601-2-24 for infusion pumps).

Furthermore the EN 1441 (risk analysis) must be observed. Moredetails of risk analysis and risk management can be found on the following pages.

// THE INTERNATIONAL VALID STANDARD IEC 60601

IEC 60601-1, third edition: What is the benefit of the revised standards ?

For the safety concepts of electrical medical devices the interna-tionally valid standard IEC 60601 is of great importance. This standardis being revised at the moment; the third edition will be publishedprospectively in 2005.

The past experiences had with this standard were used to inte-grate a number of improvements into the draft of the third edition.Because medical devices are increasingly applied in systems, the application field of the standard refers now to basic safety and thefunctional safety of devices and systems. Therefore the claims of thecomplementing standard IEC 60601-1-1 are implemented in the basicstandard. The integration of functional safety is a new idea.

The basic idea of the revised standard takes up two further veryimportant topics: safety during operation (usability), as well as risk management.

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Usability (IEC 60601-1-6): Minimisation of risks for patients and users

The new standard IEC 60601-1-6 refers to medical electric devicesand their combinations. It describes the process of ergonomic designand gives instructions, as to how this process shall be organised,carried out and documented. The usability of the concerned medicalequipment shall be so good that the fundamental safety, as well as itsessential perfomance are secured. The standard refers explicitly to useerrors and how these can be reduced to an acceptable value. Thoughthe consequences of faults as result of the irresponsible conduct liebeyond the focus of the standard.

In this context it should be mentioned that steute cooperates closely with a university institute that plays a leading role in the de-termination of ergonomics and usability of medical equipment.

Risk analysis/risk management for medical equipment

The idea of risk management known by the introduction of theISO 14971 has characterised the basic concept of the third edition ofIEC 60601-1. With it the product standard, as well as the process stan-dard, are considered.

Basically the degree of risk is determined by two factors: degreeof damage and possibilty of occurrence.

The risk analysis is in the meantime for designing engineers andsafety engineers a usual method. The risk management per ISO 14971and soon also per IEC 60601-1-1 goes beyond this. Beside the pureanalysis and determination of risk classes, it contains decisions aboutthe acceptability of the planned safety measurements, as well as thedefinition, implementation and verification of countermeasures and market observation.

Degree of damage

Fig. 1

Possibility of occurence

Risk

// RISK MANAGEMENT

ww

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Risk analysis and/or product standard?The manufacturer, meticulous to details, might question whether

a risk anylysis is obligatory in the case of an existing product stan-dard. The answer is: In principle yes, because the product standardsalso aim to define the necessary measurements, in order to reduce the risk to an acceptable degree. But the standards are oftennot state-of the-art. Thus the manufacturer should verify if the current technology is still covered by the standard.

Moreover the product standards assume standard realisations.»Exotic« concepts are often not considered. In these cases the morebasic EN 1441, describing the risk analysis, is a lot more helpful.Furthermore the product standards (partly implicitly) are based onthe assumption that certain application fields and principles are present. Thus it must be verified if the product is covered by it.Finally the product standards do not consider the optional compo-nents. Therefore it should be checked if all functions/components ofthe product are covered by the standard.

A challengeEven if the revised standard IEC 60601-1 has not been submitted

as a final draft: Its implementation will be a challenge for the manufacturers. steute has prepared for it early and profits from theknow-how of other application fields (safety switchgear for industrialapplications, switchgear for explosive-endangered areas) concerningthe application of relevant standards and methods (e. g. risk analysis,risk assessment).

Fig. 2 Fig. 3

Risk analysisEN 1441

ISO 14971-1

Risk managementISO 14971

IEC 60601-1-1

// MINIMIZE RISKS FORUSERS, PATIENTS OR OTHERTO AN ACCEPTABLE DEGREE

ww

w

Risk control

- Analysis of options- Realisation- Judgement of remaining risks- Justification of the total risk

Information from the phases after production

- Experience from market observations- Evaluation of experinces in

risk management

Risk assessment

- Decision about justification of risks

Risk analysis

- Commitment of use/destination

- Identification of hazards- Risk assessment

Risk management

Risk judgement

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// TESTS, APPROVALS, CERTIFICATES

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// TESTS, APPROVALS, CERTIFICATES

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01.2

6.03

99/1

1789

03/0

5.20

07/2

000/

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steute Schaltgeräte GmbH & Co. KG Medical equipmentBrückenstraße 9132584 Löhne, GermanyTelephone + 49 (0) 57 31 7 45-0 Telefax + 49 (0) 57 31 7 45-200 E-mail [email protected]

Beside foot-operated controls formedical equipment steute Schalt-geräte designs and producesswitchgear for complex and criti-cal applications for industrial applications – for example pull-wire, door handle, foot switchesand safety switchgear.

Furthermore steute boasts a wideprogram of explosive protectedswitchgear that are appliedwhere flammable atmospherescan occur – e. g. Ex position swit-ches, Ex pull-wire switches,Ex safety switches and solenoidinterlocks, as well as Ex magneticsensors.

SAFE SWITCHGEAR FOR COMPLEX AND CRITICAL APPLICATIONS // Medical equipment … · 2017-04-27 ·...

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Transcript of SAFE SWITCHGEAR FOR COMPLEX AND CRITICAL APPLICATIONS // Medical equipment … · 2017-04-27 ·...