PowerCube-Ergo Cardiopulmonary Function Testing Operating Instruction Manual Rev 01 Sept 2009

GANSHORN Medizin Electronic GmbH PowerCube-Ergo-CASE_ENG_rev.01, 01.09.2009

Operating Instruction Manual Ref.No. 03 140 0 222 Preface, page 2 of 14

GANSHORN Medizin Electronic GmbH

Operating Instruction Manual Ref.No. 03 140 0 222

PowerCube-Ergo-CASE_ENG_rev.01, 01.09.2009

Table of Contents Preface 1

Technical Information

2

Safety Regulations

3

System Description

4

Assembling and Initial Start-up Operation

5

Calibrations and Tests

6

Performing Measurements

7

Hygiene

8

Maintenance and Technical Service

9

Environmental Protection

10

Accessories, Disposables and Spare Parts

Preface, page 3 of 14

GANSHORN Medizin Electronic GmbH

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Preface Contact Addresses

Warranty Product Changes Trademarks and Patents Copyright Documentation Order No. Related Documents Copyright General Notes Update

Intended Use, Documentation Purpose, Target Group, and Safekeeping System Description Intended Use Documentation Purpose Target Group Indications and Contraindications PowerCube-Ergo Requirements for Operating Personnel Requirements for Installation, Maintenance and Service Requirements for Maintenance and Service Personnel Requirements during Running Operation Operator’s Duty Safekeeping of this Documentation Supplementary Documentation and Training

Definitions Danger Warning Caution Application Instructions and Other Useful Information Action Instructions / Operating Steps Lists Cross Reference Cross Reference to Possible LF8 Settings Keys and Buttons Equipment Identification

Equipment Symbols

GANSHORN Medizin Electronic GmbH

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Preface Dear customer, We would like to thank you for the trust that you have shown in us through the purchase of a GANSHORN product. You have purchased a product that has been developed and constructed using state-of-the-art technology. All manufacturing processes are subject to strictest quality control. If you use original GANSHORN accessories and replacement parts, we guarantee the best quality and operational safety. We continually strive for the further development and improvement of our products. Suggestions for improving our products are always welcome. If you should have any questions or suggestions, then please get in touch with us.

Peter Ganshorn Ganshorn Medizin Electronic GmbH Niederlauer – GERMANY -

Contact addresses Manufacturer and publisher

Distributed by:

Ganshorn Medizin Electronic GmbH Industriestr. 6-8 97618 Niederlauer Germany

GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 USA

Tel. Fax

Tel:

+49 9771 6222-0 +49 9771 6222-55

Fax: [email protected] www.ganshorn.de

Designated as GANSHORN in this document.

+1.414.355.5000 800.558.5120 (USA) +1.414.355.3790

GANSHORN Medizin Electronic GmbH

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Warranty Patient safety, the retention of the stated measurement precision and the best possible functioning is only guaranteed if original GANSHORN parts are used for GANSHORN devices. Accordingly, only original GANSHORN parts may be utilized that have been listed in this documentation and in complementary documentation and that have been inspected and approved by GANSHORN. If non-original parts are used in GANSHORN devices, GANSHORN does not guarantee the safe operation and functioning of its products. In that case, the GANSHORN guarantee expires. No guarantee claims can be made in the case of damage resulting from utilization of non-original parts in GANSHORN devices. GANSHORN regards itself as responsible for its products concerning safety, reliability, precision, and function only if: Assembly, installation, expansion, modification, adjustment, changes, and repairs have been carried out by GANSHORN or authorized GANSHORN partners The GANSHORN product has been employed in accordance with the operator instructions The GANSHORN product has been employed in accordance with the intended use.

GANSHORN is liable for the function capability, but not for the absolute lack of defects of its software programs. GANSHORN is only liable for the function capability of its software that is used with GANSHORN systems. GANSHORN does not guarantee the flawless functionality of GANSHORN software programs in connection with any external software programs, and does not accept liability for malfunctions and/or their consequences.

Product Changes We reserve the right to make changes in construction that are in the interest of technical progress at any time.

Trademarks and Patents Trademarks PowerCube BodyScope ProvoJet SpiroJet BodyLiveCal SpiroScout These are trademarks owned by GANSHORN. All other marks in this documentation are owned by their respective owners

Copyright All rights are reserved and retained by the manufacturer for products, circuits, processes, software programs, names, trademarks, and patents.

GANSHORN Medizin Electronic GmbH

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PowerCube-Ergo-CASE_ENG_rev.01, 01.09.2009

Preface, page 7 of 14

Documentation Order No.

03 140 0 222

Valid for.:

PowerCube-Ergo / CASE

Related documents: Operating Instruction Manual LF8, Ref. No. 03 140 0 242 Customer information Copyright

2009, GANSHORN Medizin Electronic GmbH

Revision History Release date:

Release number:

Comment:

30 January 2009

01/2009, index a

Initial release

09 March 2009

01/2009, index b

Chapter 10: cancelling of accessories ref.no. 2044243-006 and 2044243-023

01 September 2009

Rev.01

Change of the release number Change of the ref. number system Revision of the English translation Appendix Customer information Suitable disinfectants

The release number changes with every update for this documentation General Notes All GANSHORN documents correspond to the state of the underlying safety standards at the time of printing. All illustrations in this documentation are provided as examples only. They may not necessarily reflect your equipment setup or data displayed. All pictured GANSHORN products and screen displays can deviate, due to technical changes. All rights, including reprints, copying, and those from translation remain reserved by the publisher. No part of this documentation may be reproduced in any form whatsoever or copied using electronic reproduction systems without the publisher’s express written permission. Update This documentation is also regularly reviewed. Changes, technical improvements, as well as any typographical errors are taken into consideration in each following issue. Technical changes/modifications made on the devices after the issue date are not contained in this documentation. Changes/modifications performed on GANSHORN products that affect the hardware and software must be documented in a Medical Device Book. The operator must be accordingly trained concerning the changes/modifications. This must subsequently be documented in the Medical Device Book. In the case of non-observance, the manufacturer is not liable.

GANSHORN Medizin Electronic GmbH

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PowerCube-Ergo-CASE_ENG_rev.01, 01.09.2009

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Intended Use, Documentation Purpose, Target Group and Safekeeping System Description The PowerCube-Ergo is a software-driven, cardio-pulmonary exercise system providing breath-by-breath measurements of flow, oxygen uptake, carbon dioxide production and optional heart rate. It measures the human response of increasing exercise with emphasis on the gas exchange and ventilation parameters. The results of the test can be displayed on a PC and can be printed after the test if a printer is connected to the PC. Intended Use The PowerCube-Ergo is intended for medical applications requiring a non-invasive assessment of the cardiopulmonary response to exercise or measurement of energy expenditure using indirect calorimetry. The PowerCube-Ergo is intended to be used on adults and adolescent patients. The PowerCube-Ergo is intended to be used by trained operators under direct supervision of a licensed health care practitioner, in hospitals, clinics, physician offices and outreach centres. The PowerCube-Ergo Ergospirometry module is intended for use with a personal computer system to run the measurement software, but also as part of a cardiopulmonary exercise testing system. The PowerCube-Ergo, using LF8, is not meant to be used for any purpose other than those named herein. If it is used for purposes that do not meet its intended use, this is regarded as an unauthorized utilization! WARNING

INTENDED USE If LF8 and the PowerCube-Ergo are used for purposes other than their intended use, a safe operation of LF8 and the PowerCube-Ergo is not possible! GANSHORN is not responsible for any personal and physical damage that results from non-intended utilization of LF8 and the PowerCube-Ergo; the operator is responsible! Protective measures Carefully read the documentation available in order to use LF8 and the PowerCube-Ergo in their intended applications! Obey all instructions contained in the documentation, especially the safety regulations and warning notices!

Documentation purpose This document contains the instructions necessary to operate the equipment safely and in accordance with its function and intended use. Where necessary this documentation identifies additional sources of relevant information and/or technical assistance. This instruction manual completes the “Operating instruction manual LF8 – software for pulmonary function testing”. The operator is responsible for updating the existing documentation and for instructing the responsible personnel. The integrity of the existing documentation is to be periodically inspected by the operator. This document serves for education, instruction, and as a reference work when dealing with the GANSHORN device described in this documentation. In this documentation, you will find information about the position and function of all hardware operating and display elements relevant to a safe and fluent operation, as well as warning notices, displays and signals. Furthermore, this documentation will help you localize possible errors during malfunctions, and, in the case of minor malfunctions, show how to correct them. Carefully read through the entire documentation. Especially take note of the special safety regulations for this GANSHORN device => Chap. 2 Safety Regulations

GANSHORN Medizin Electronic GmbH

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Target Group This documentation is geared for clinical professionals, especially Doctors Medical assistants Nurses Service technicians The responsible device operator Other persons meeting the requirements of performing personnel Clinical professionals are expected to have working knowledge of medical state-of-the-art, procedures, practices and terminology as required for completing these examinations. Indications and Contraindications PowerCube-Ergo The PowerCube-Ergo allows the user to: screen for early signs of cardiac or pulmonary dysfunctions differentiate heart and lung limitations evaluate dyspnoea complaints classify patients in comparison to reference values detect ventilatory threshold generate user specific workout programs assess medication and training results Ergospirometry and hence the PowerCube Ergo is not applicable for patients with acute myocardial infarction or ischemia unstable angina serious cardiac dysrhythmias endocarditis severe aortic or mitral stenosis severe left ventricular dysfunction acute pulmonary embolus/infarction any acute or serious non-cardiac disorder or any severe physical handicap Requirements for Installation, Maintenance and Service GANSHORN devices are only allowed to be installed, put into service and maintained in accordance with the actual regulations and standards. Medical electronic devices feature special safety requirements concerning electromagnetic compatibility and have to be installed and put into service according to the EMC-instructions of the accompanying documents. Portable and mobile HF-communication devices (e.g. mobile phones, DECT-phones etc.) may disturb medical electrical devices. Interference may occur in the vicinity of equipment marked with the following symbol: Requirements for Maintenance and Service Personnel Installation, initial operation, all changes, modifications, expansions, repairs, maintenance measures including safety control and metrological/safety control, and any other work on GANSHORN products may only be performed by GANSHORN or by an authorized GANSHORN partner. The enclosures of GANSHORN devices may only be opened by GANSHORN or by an authorized GANSHORN partner. If this device is modified appropriate inspection and testing must be conducted to ensure continued safe use of the device. After each maintenance control or other operation with the device or the system a metrological control and safety control is necessary. Each metrological control demands a succeeding safety control.

GANSHORN Medizin Electronic GmbH

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WARNING

Preface, page 10 of 14

RISK OF ELECTRIC SHOCK The operator is not allowed to do maintenance work on the device. Don’t open the enclosure! The device does not contain any part that the operator can exchange himself. Only GANSHORN or an authorized GANSHORN partner is allowed to open the device.

Requirements during Running Operation GANSHORN devices may only be used in accordance with the supplied operating instructions. The operator must be trained in, instructed in, and authorized for use of GANSHORN devices. Instruction of at least one person is necessary duty after installation. If, after installation no person becomes nominated and instructed, GANSHORN cannot be held responsible for damage resulting from incorrect use of the system. All persons who are involved with the PowerCube-Ergo must thoroughly read and understand the operating instructions supplied. They must confirm that they have understood the operating instructions by signature. A successfully completed orientation of both – instructor and trainee – must be documented in writing in the Medical Product Book. The individual authorizations are to be clearly established. Operating personnel who are being trained may only work on the PowerCube-Ergo under the supervision of a person who is familiar with the operation of the PowerCube-Ergo. Requirements for Operating Personnel The PowerCube-Ergo is intended for use by trained and instructed personnel The operator must be familiar with the operation of the PowerCube-Ergo. Medical devices may only be operated by personnel who can ensure proper operation based on their training or knowledge, and practical experience. In order to be allowed to operate the system, the operator has to be trained and instructed. The operator has to read the entire operating instructions and related documents carefully, especially the “Operating instruction manual LF8 – software for pulmonary function testing”. The operator has to pay special attention to all safety regulations and warning notices. The PowerCube-Ergo is a PC-based system for pulmonary function testing under the direct supervision of a health-care practitioner. The physician in charge must interpret the numerical and graphical results in the entirety of the existing patient data. Evaluation/interpretation hints from the computer are always to be understood as non-binding suggestions for the physician. The PowerCube-Ergo eases the physician’s and trained operator’s work with the patient – in no way do they release them from their medical and nursing responsibilities! The correct performance of the measurement, the creation of a diagnosis, as well as initiating suitable treatment methods, is the exclusive responsibility of the operator and the supervising physician. The quality of the measurements must be considered when interpreting the results. The quality of the pulmonary function measurement results is largely dependent on the cooperation of the patient. Then again this depends on how qualified the operating personnel is to motivate and animate the patient to perform measurement of acceptable high quality.

GANSHORN Medizin Electronic GmbH PowerCube-Ergo-CASE_ENG_rev.01, 01.09.2009

Operating Instruction Manual Ref.No. 03 140 0 222 Preface, page 11 of 14

Operator’s Duty The operator is responsible the functional safety and the proper condition, including maintenance, of the GANSHORN device. All GANSHORN devices have been developed and produced under consideration of a risk analysis and after careful selection of the harmonized standards that are to be maintained, as well as additional technical specifications. They therefore correspond to state-of-the-art technology and insure the highest degree of safety. However, this safety can only be achieved in operating practice if all necessary measures have been met. It is the duty of the operators of GANSHORN devices to take due care to plan these measures and to supervise their execution. Especially the operator must ensure that o o o o o o o o o o o o

The GANSHORN device is only utilized for the intended use The GANSHORN device is only used in good functioning condition. The devices are regularly inspected for their security and functional efficiency The safety devices are regularly inspected for their functional efficiency The necessary system calibrations are regularly carried out All necessary personal protection gear is available and is being used by the operating, cleaning, maintenance and service personnel These operating instructions are always complete and are available in legible condition at the location where the GANSHORN devices stands Exclusively qualified and authorized personnel operate, clean, maintain and/or repair the GANSHORN device The operating personnel is regularly instructed on work safety and environmental protection in the necessary scope The operating personnel has knowledge of these operating instructions, especially the safety regulations and warning notices contained therein All safety and warning notices attached to GANSHORN devices are always legible, not covered, and not removed No changes or modifications to the GANSHORN device have been done by nonauthorized persons

Safekeeping of this Documentation This document is part of the GANSHORN device and has to be kept close to it at all times. The exact observance of this documentation is a prerequisite for the regulation-utilization and for the correct operation of the GANSHORN device described, as well as safety of the patient and the operating personnel dependent on it. All safety regulations of the GANSHORN system that run with this software must be observed. These are written in chapter 2 of this documentation. Supplementary Documentation and Training Additional documentation and information, also concerning training can be purchased from your authorized GANSHORN dealer or directly from GANSHORN.

GANSHORN Medizin Electronic GmbH

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Definitions The terms Danger, Warning and Caution are used throughout this documentation and related documents in accordance with ANSI Z535.4 to point out hazards and to designate a degree or level of seriousness. Familiarize yourself with their definitions and significance. Hazard is defined as a source of potential injury to a person. The safety notes presented in this documentation refer to the equipment in general. The order in which safety statements are presented in no way implies order of importance. Danger Indicates an imminent hazard which, if not avoided, will result in death or serious injury Warning Indicates a potential hazard or unsafe practice which, if not avoided, could result in death or serious injury Caution Indicates a potential hazard or unsafe practice which, if not avoided, may result in minor personal injury or product/property damage Example: Level of seriousness

Kind of hazard Text…………………………………………. Text…………………………………………. Text…………………………………………. Text………………………………………….

For application instructions and other useful information INFORMATION Text………………………………………….. Text………………………………………….. Text…………………………………………..

Action Instructions / Operating Steps Explanation ………………………………………….. = Consequence / effect………………………………………….. Lists Text………………………………………….. Text………………………………………….. Text………………………………………….. Text………………………………………….. Text…………………………………………..

Cross Reference Cross references are written as follows: => Chap. 2, Safety Regulations

GANSHORN Medizin Electronic GmbH

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Cross Reference to Possible LF8 Settings (LF8 screen “system”, see related “Operating instruction manual LF8 – software for pulmonary function testing”!) Possible customizing in the LF8-settings is written as follows: Setup/register-card/register card line number (e.g. setup/general/64) Keys and Buttons Framed text indicates keys displayed on the user interface of the software, e.g. Start = software button labelled with “Start” Angle brackets indicate keyboard keys, e.g. <Alt> = keyboard key labelled with “Alt” Equipment Identification Every GANSHORN device has a unique serial number for identification. The serial number “SN” appears on the device label.

GANSHORN Medizin Electronic GmbH

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Equipment Symbols Symbol

Description Consult accompanying documents Consult instruction manual

REF REV SN

Article number, below article number as code (Code 39, without check digit) Actual revision of this device Every GANSHORN device has a unique serial number for the identification on the device label. Format: Revision-aa-mm-yyyy-bb-cccc. aa= number or series, mm= month manufactured, yyyy=year manufactured, bb=internal product code, cccc = continuous number Below the serial number as bar code (Code 39, without check digit) CE-mark with number of notified body Class of protection II Type BF applied part

IP 20

Label Rev.

Housing degree of protection This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment The number found at the right of this symbol is the date of manufacture in the yyyy-mm format. At the right of the date you find the country of origin. The address found at the right of this symbol is the address of the manufacturer of this device. The name below this symbol is the device’s brand name (e.g. “PowerCube”) Actual revision of this label Position for GANSHORN quality assurance label

Power supply safety advice (near Power input) Authorized representative in the European Community Quantity of articles packed Federal law restricts this device to sale by or on the order of a physician Non - steril Symbols for correct handling of the device. (Humidity limitation, Atmospheric pressure limitation, Temperature limitation, Keep dry) Fragile, handle with care - Symbol for correct handling of the packing Top, Symbol for correct handling of the packing

GANSHORN Medizin Electronic GmbH PowerCube-Ergo-CASE_ENG_rev.01, 01.09.2009

Chapter 1 :

Operating Instruction Manual Ref.No. 03 140 0 222 Chapter 1, Technical Information, page 1 of 8

Technical Information

GANSHORN Quality Management CE Mark Information Quality Management System

General Information Package Contents Accessories Minimum Requirements of the Computer System

Technical data PowerCube-Ergo Technical Data Cables, Cable Lengths and Accessories Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the PowerCube-Ergo

GANSHORN Medizin Electronic GmbH PowerCube-Ergo-CASE_ENG_rev.01, 01.09.2009

Operating Instruction Manual Ref.No. 03 140 0 222 Chapter 1, Technical Information, page 2 of 8

GANSHORN Quality Management CE Mark Information The GANSHORN device bears the CE mark of the officially notified body indicating its conformity with the provisions of the Annex II of the Medical Device Directive MDD 93/42/EEC.

Quality Management System GANSHORN has adopted a quality management system in accordance with EN ISO 13485:2003 + AC:2007 and EN ISO 9001:2000 which has been inspected and certified by an officially notified body.

GANSHORN Medizin Electronic GmbH

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General Information Package Contents The basic accessories included can be extracted from the delivery note. Check for completeness and any possible damage immediately after receipt of the delivery. Missing and damaged parts are to be immediately reported and claimed to the shipping contractor. An additional report to GANSHORN or your authorized GANSHORN partner is recommended. Accessories The basic accessory package is compiled so that the delivered GANSHORN device is ready to use after installation and start-up operation. The exceptions here are the calibration and measurement gas bottles, that, due to logistical and safety reasons, must be purchased and supplied by the local operator. GANSHORN reserves the right to make changes in the content of the respective accessory packet at any time. Additional accessories for the running operation, disposable material and spare parts, can be ordered from GANSHORN or your authorized GANSHORN partner. WARNING

ORIGINAL GANSHORN PARTS Patient safety, operator safety, measurement accuracy within the given limits and highest possible trouble free running of the GANSHORN device can only be ensured if GANSHORN parts are used for GANSHORN devices. So only original GANSHORN parts may be utilized, those that have been listed in this documentation and in supplementary documentation and that have been inspected and approved by GANSHORN. If non-original parts are used in GANSHORN products, GANSHORN does not guarantee the safe operation and functioning of its products. In that case, the GANSHORN guarantee expires. No guarantee claims can be made in the case of damage resulting from utilization of non-original parts in GANSHORN systems. => Chap. 10, Accessories, Disposables and Spare Parts

Minimum requirements of the computer system

The minimum requirements will depend on the complete system. For further information about hardware and software requirements please refer to the software instruction manual for LF8 => Operating Instruction Manual LF8, Ref.No. 03 140 0 242, Chapter 4, Data Management and to the operating instruction manual of the complete system (CASE ES)

GANSHORN Medizin Electronic GmbH

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Technical Data PowerCube-Ergo GANSHORN reserves the right to modify the construction in the interest of technical progress at any time.

General Software Classifications Device classification Application section Ambient sensors Ambient temperature Atmospheric pressure Corrections F/V processing Inspiratory volume quantities auto correction Gas volume Computer interface Signal transmission Flow measurement Measurement principle Measuring range Accuracy

LF8 32 bit for Windows

®

Active medical product, class IIa Type BF 0 to 50 °C 500 to 1050 mbar ERS or ATS BTPS (environment module) STPD (environment module) 4 kV optoisolator RS232-interface, 57,600 Baud Pneumotachograph with variable orifice 0 to ± 18 l/s < ± 3% or 50 ml/s (the larger value applies) PEF: ± 5% or 150 ml (the larger value applies). Meets ERS/ATS standards 10 ml/s Digital Integration Not limited, graphical display 0 to 10 l 10 ml

Resolution Volume measurement Range Resolution O2-Measurement Measurement principle Solid state oxygen SSO (zirconia) Measuring range 10 to 21% O2 Resolution 0.01% O2 Rise time (10-90 time) <100 msec Accuracy ± 0.1% O2 CO2-Measurement Measurement principle Ultrasonic Measuring range 0 to 15 % CO2 Resolution 0.01% CO2 Rise time (10-90 time) <100 msec Accuracy ± 0.1% CO2 Power supply PowerCube-Ergo External plug-in power Egston N2EFMW3 med.use supply Protection class class II Primary voltage range 100 to 240 VAC; 50 to 60 Hz; 550 mA Ambient conditions, Operation Ambient temperature +15 to + 35 °C Relative humidity 30 to 80 % (non condensing) Atmospheric pressure 700 to 1050 hPa Max. warm up time 30 min Max. temp. gradient 3°C / hour Ambient conditions, storage and transportation Ambient temperature -20 to +50°C Relative humidity 10 to 90 % (non condensing) Atmospheric pressure 600 to 1050 hPa Dimensions [W x H x D] PowerCube-Ergo Approx. 15x 15 x 15 cm Weight PowerCube-Ergo Approx. 2.4 kg

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Cables, Cable Lengths and Accessories Listing of the cables and cable lengths, transducers and other accessories for which GANSHORN claims compliance with sections 36.201 and 36.202: Cable description

Type

Length

Remarks

Mains power line

Triple conductor cable

250 cm

Xx

RS232 connection

Shielded cable

> 300 cm

xx

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The POWERCUBE ERGO SYSTEM is suitable for use in the specified electromagnetic environment. The customer and/or the user of POWERCUBE ERGO SYSTEM should ensure that it is used in an electromagnetic environment as described below. Emissions Test

Compliance

Electromagnetic Environment Guidance

RF Emissions CISPR 11

Group 1

The POWERCUBE ERGO SYSTEM uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF Emissions CISPR 11

Class B

Harmonic emissions

Class A

The POWERCUBE ERGO SYSTEM is suitable for use in all establishments including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

IEC 61000-3-2 Voltage fluctuations / flicker emissions IEC 61000-3-3

Complies

GANSHORN Medizin Electronic GmbH

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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The POWERCUBE ERGO SYSTEM is suitable for use in the specified electromagnetic environment. The customer and/or the user of POWERCUBE ERGO SYSTEM should ensure that it is used in an electromagnetic environment as described below. Immunity Test Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transients/burst IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

IEC 60601-1-2 Test Level

Compliance Level

Electromagnetic Environment Guidance

+ 6 kV contact

+ 6 kV contact

+ 8 kV air

+ 8 kV air

+ 2 kV for power supply lines

+ 2 kV for power supply lines

1 kV for input/output lines

1 kV for input/output lines

+ 1 kV differential mode

+ 1 kV differential mode

+ 2 kV

+ 2 kV

common mode

common mode

< 5% UT for 0.5 cycle (> 95 % dip in UT)

< 5% UT for 0.5 cycle (> 95 % dip in UT)

Mains power quality should be that of a typical commercial and/or hospital environment

40% UT for 5 cycles (60 % dip in UT)

40% UT for 5 cycles (60 % dip in UT)

70% UT for 25 cycles (30 % dip in UT)

see risk analysis

If the user of the POWERCUBE ERGO SYSTEM requires continued operation during power mains interruptions, it is recommended that the POWERCUBE ERGO SYSTEM be powered from an uninterruptible power supply or a battery.

< 5% UT for 5 sec (> 95 % dip in UT)

< 5% UT for 5 sec (> 95 % dip in UT)

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial and/or hospital environment

Mains power quality should be that of a typical commercial and/or hospital environment

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The POWERCUBE ERGO SYSTEM is suitable for use in the specified electromagnetic environment. The customer and/or the user of POWERCUBE ERGO SYSTEM should ensure that it is used in an electromagnetic environment as described below. Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 NOTE

3 A/m

3 A/m

UT is the a.c. mains voltage prior to application of the test level

The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low.