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Summary of Contents for GERATHERM Spirostik Complete
- Page 1 Spirostik Complete Serial numbers: xx|8|102|yyy and 2103xxxxx Instructions for Use Version: 7 Release date: 14. July 2021 Please read carefully and store in a place which is always accessible for future consultation!
- Page 2 Language: English Affected serial numbers: xx|8|102|yyy and 2103xxxxx Software version: valid from 1.1.0 Geratherm® Respiratory GmbH Kasernenstraße 4 97688 Bad Kissingen, GERMANY Tel.: +49 (0)971 7857043-0 Fax: +49 (0)971 7857043-30 info@geratherm-respiratory.com 0494 www.geratherm-respiratory.com EUDAMED SRN: © Geratherm® Respiratory GmbH DE-MF-000006818...
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Page 3: Table Of Contents
Consumable Items / Auxiliary Materials ......... 24 Safety in Handling ..............25 General Safety at Work and Personnel Qualification ..... 26 The technical state of Spirostik Complete and construction..27 Operation / Servicing and Maintenance ........29 Electromagnetic Compatibility (EMC) ..........30 Cleaning and Disinfection ............. - Page 4 Establish operational readiness............. 52 Inserting the Flow Sensor ............. 54 Calibrating Spirostik Complete ............. 55 Using Spirostik Complete / Carrying Out Measurements ....56 Removing the Flow Sensor ............57 Establishing Energy Saving Mode / Standby Mode ....... 58 Switching off the Spirostik Complete ..........58 Servicing / Maintenance ............
- Page 5 12.3.1 Spirostik Complete with Medical Device Cart and Isolation Transformer .................. 75 12.3.2 Spirostik Complete without Medical Device Cart and without Isolation Transformer (combined with Non-Medical Device(s)) ....76 12.3.3 Spirostik Complete without Medical Device Cart and without Isolation Transformer .................. 77 12.4...
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Page 6: General Information
This IFU is a component of the product in accordance with DIN EN ISO 60601-1. It should make it easier to familiarise yourself with Spirostik Complete, as well as give you instructions about its intended use and safe operation. This IFU has been written for healthcare professionals who are qualified to perform spirometric examinations. -
Page 7: Abbreviations
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx If, in spite of careful reading of this IFU, you require more information, please contact your specialist retail partner on site. You can obtain the contact details via a form provided by the manufacturer at www.geratherm-respiratory.com/login/. - Page 8 Not observing and not avoiding the situation may lead to minor or moderate injuries. Not observing this warning information may lead to faults or malfunctions of the Spirostik Complete or may indicate that Attention something in its environment may be damaged.
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Page 9: Symbols
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx Symbols Symbols displayed in this IFU, on the medical device itself and / or on its packaging are standardised symbols. Symbol Explanation Follow the instructions for use! Applied part from type BF corresponding to... - Page 10 Serial no.: xx|8|102|yyy and 2103xxxxx Symbol Explanation For single use only! This symbol does not refer to the Spirostik Complete itself, but to the consumable items used in connection with it. This is applied to the respective packaging and must be observed.
- Page 11 Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx Symbol Explanation Fragile, handle with care The package contains a product that must be handled with appropriate care to prevent damage during transport and storage. Keep away from rain The package contains a product that must be protected from moisture during transport and storage.
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Page 12: Copyright
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx Copyright The manufacturer reserves all rights to this document and the information contained therein. No part of this document or the information contained herein may be reproduced or transmitted without the written consent of the manufacturer. All information or brand names of a third party contained in this document are subject to the copyright of that third party. -
Page 13: Conditions Of Use
Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx Conditions of Use Any other use of Spirostik Complete which is not described in this IFU is deemed improper use. The responsible organisation of Spirostik Complete alone is liable for any direct or indirect damage resulting from not adhering to these conditions. -
Page 14: Indication
2.1.1 Indication With Spirostik Complete, pulmonary function examinations can be carried out for diagnosing, monitoring of process, screening and assessing the severity of pulmonary diseases. In particular, this includes: Obstructive diseases •... -
Page 15: Contraindication And Side Effect
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx 2.1.2 Contraindication and Side Effect 2.1.2.1 Contraindicationen The following contraindications apply for spirometric examinations: Contraindications Absolute Relative Patients with a new (< 1 month old) myocardial infarction Aneurysm of the ascending aorta... -
Page 16: Side Effects
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx 2.1.2.2 Side Effects If there are no contraindications and the examination is carried out in accordance with the descriptions in the IFU, side effects rarely occur in pulmonary function examinations. These can be... -
Page 17: Definition Of The Groups Of People
Spirostik Complete on the patient after verifiable instruction by the responsible organisation and / or is responsible for rectifying faults to the Spirostik Complete, as well as its calibration. Users must be aware of the clinical meaning and, for example, be a physician, physician’s assistant, assistant or trained... -
Page 18: Intended Use
Respiratory GmbH products via the universal software BLUE CHERRY®. (See chap. 4.1.4 “System Construction and Electrical Safety”) In all cases, the Spirostik Complete is only intended for use in closed, pleasantly temperature-controlled (19 °C - 25 °C) rooms in a clinical area. -
Page 19: Original Spare Parts / Accessories / Optional Expansions
Electromagnetic compatibility (EMC) in accordance with DIN EN 60601-1-2:2016-05; VDE 0750-1-2:2016-05; IEC 60601-1- 2:2014. See chap. 12.4 “Electromagnetic Compatibility / EMC Guidelines”. Spirostik Complete is suitable for use in all institutions including those in residential areas and those which are directly Attention connected to the public supply network which also supplies buildings used for residential purposes. -
Page 20: Original Spare Parts / Accessories
Further information on PC systems approved by the manufacturer in chap. 12.1 "Technical Data". Component Description / name Supply scope in units Spirostik Complete, 10 Inch 278149 Desktop Spirometry system [old:40.022] with integrated Windows 10 PC system 10 inch touch screen and thermal printer. - Page 21 Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx Component Description / name Supply scope in units Power Supply Cable (Power 348869 (EU) 599760 (USA) Cord) Plug Type IEC 60320 996996 (CHE) 582042 (ITA) 261426 (UK) 578417 (CHN/AUS) Power cord with European plug for use with power [old:10.838]...
- Page 22 Guide Rolls for Paper Roll 191465 Set of 2 guide rolls for [old:10.808-01] proper positioning and easy unrolling of paper roll in Spirostik Complete. Quick Start Guide, 229372 Spirostik Complete [old:40.020-03] Short instruction manual for quick start of Spirostik Complete.
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Page 23: Optional Expansions
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx 2.2.1.2 Optional Expansions The following add-ons can be purchased via specialist retail partners. You will find: • A list of specialist retail partners as an insert in this IFU or in your medical device book, as well as the most updated version at www.geratherm-respiratory.com/login/... -
Page 24: Consumable Items / Auxiliary Materials
Spirostik Complete Handle 373982 Simple to use snap-in handle for [old:40.012] connection of Spiraflow disposable flow sensor with Spirostik Complete. For wipe disinfection, alcoholic quick-acting depend- Disinfectant Bacillol Tissues (BODE Chemie GmbH) ing on SprayIn (Dr. Deppe GmbH) -
Page 25: Safety In Handling
In spite of this, dangers of injury to users / operators, patients and third parties as well as damage to Spirostik Complete or other materials may occur if this is: •... -
Page 26: General Safety At Work And Personnel Qualification
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx General Safety at Work and Personnel Qualification Possible danger to life. Reason: Not complying with health and safety regulations. Ignoring essential preventive measures. Therefore: • Always comply with general national regulations... -
Page 27: The Technical State Of Spirostik Complete And Construction
Therefore: • Do not overstress Spirostik Complete! Use with care! • Do not modify or use Spirostik Complete or total system contrary to the respective manufacturer's specification! • Under no circumstances use or connect any devices, systems, equipment and other products... - Page 28 Request maintenance work from your authorised specialist retail partner! Reason: Electrical shock. Therefore: • Only connect the Spirostik Complete to a supply system with a protective earth conductor! Page 28 Version: 7 | Release date: 14. July 2021...
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Page 29: Operation / Servicing And Maintenance
Therefore: • In principle, observe chap. 12 “Technical Specifications”! • Do not operate Spirostik Complete if there are flammable or explosive gases in the room! • Do not operate Spirostik Complete near the magnetic field of an MRT system! Possible danger to life. -
Page 30: Electromagnetic Compatibility (Emc)
Therefore: • While using Spirostik Complete, do not use any transmitting devices (e.g. mobile phones, portable phones, power lines …) within close proximity (< 30 cm) that exceed the immunity levels as specified in the EMC guidelines! •... -
Page 31: Cleaning And Disinfection
Possible danger to life. Reason: Cross-contamination. For this: Observe the general medical principles! Therefore: • Clean and disinfect the Spirostik Complete and its reusable components as instructed by the manufacturer at regular intervals as specified! Possible severe physical injury. Reason: Contamination with transferable germs during improper disposal. -
Page 32: Structure And General Function Of Spirostik Complete
[8] Handle with inserted Spiraflow (see also chap. 7.3) [9] Display LED standby-button (see also chap. 4.1.2.2) [10] 10 inch touch screen (see also chap. 4.1.2.3) [11] „Spirostik Complete“ device with integrated Windows 10 PC system and thermal printer Page 32... -
Page 33: Operating And Display Elements
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx 4.1.2 Operating and Display Elements 4.1.2.1 Display Status LED Status LED On the back of the Spirostik Complete for power supply status indication. Display Explanation Action NONE Device switched off... -
Page 34: Display And Led Standby Button
PC system in standby mode Switch on the PC system (flashing) (Energy saving mode) with the LED standby button. WHITE Spirostik Complete ready for Measurement can be operation started (see chap. 7.5). Page 34 Version: 7 | Release date: 14. July 2021... -
Page 35: Display
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx 4.1.2.3 Display The operating system and the installed BLUE CHERRY® diagnostic software platform can be operated directly with the integrated touch screen. BLUE CHERRY® has an integrated On-Screen Keyboard for data input. The screen also serves to display all relevant information. -
Page 36: Connections / Interfaces Of The Spirostik Complete
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx 4.1.3 Connections / Interfaces of the Spirostik Complete 4.1.3.1 Handle, Peripherals, Power At the backside of the device you will find: Status LED For status indication of the power suppy. -
Page 37: Network, Peripherals, Display, Sound
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx 4.1.3.2 Network, Peripherals, Display, Sound On the left side of the device you will find: Micro- phone Line-Out HDMI Port USB 3.0 Interfaces (2 pieces) RJ 45 Network Socket (4 KV galvanically isolated) Version: 7 | Release date: 14. -
Page 38: Flow Sensor
Attention • Exactly follow instructions for cleaning, disinfection and calibration! The heart of the Spirostik Complete is the Spiraflow flow sensor. The Spiraflow is a disposable sensor and the measuring accuracy is constantly checked during production. As the flow sensor ensures the precise flow measurements, the cleaning and calibration requirements must absolutely be adhered to, regardless of the version selected. -
Page 39: System Construction And Electrical Safety
Serial no.: xx|8|102|yyy and 2103xxxxx 4.1.4 System Construction and Electrical Safety The Spirostik Complete can be operated with the included medical power supply unit and due to the integrated computer on which the BLUE CHERRY® application software is installed, it is an independent medical electrical system (ME System).This system can also be expanded due the possibility of connecting approved peripherals. - Page 40 Independent of this, the following should also be observed: Possible danger to life. Reason: Electric shock. Misdiagnosis. Therefore: • Do not modify or use the Spirostik Complete or total system contrary to the respective manufacturer's specification! • Under no circumstances use or connect any...
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Page 41: Data Connection / Computer / Printer
4.1.4.1 Data Connection / Computer / Printer The data connection between measuring electronics and computer is already integrated in the Spirostik Complete. The integrated Windows 10 PC system of the Spirostik Complete has various interfaces for connecting peripheral devices and for integration into a network. -
Page 42: Power Supply
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx 4.1.4.2 Power Supply To use the Spirostik Complete, the medical power supply must be connected continuously. Possible danger to life. Reason: Electric shock due to lack of galvanic separation with composition of non-approved components. -
Page 43: Technical Protection Measures
Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx Technical Protection Measures Spirostik Complete has been designed and built in accordance with the recognised state of technology and the requirements of the applicable, safety-relevant regulations. The technical safety condition is checked by the authorised specialist retail partner of the manufacturers within the framework of technical monitoring (see also chap. -
Page 44: Transport Storage And Assembly
Unpacking and transport to the actual place of use are the responsibility of the responsible organisation. Storage The Spirostik Complete is a mobile, portable device that can be transported safely and securely in its case and stored and kept in an organised manner. -
Page 45: Assembly
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx Assembly Assembly work is not required for the initial operation of Spirostik Complete, as this is supplied in a ready-for-operation state. As a consumable, the flow sensor must be replaced constantly, which is therefore not considered assembly. -
Page 46: Operation
Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx Operation The initial operation of Spirostik Complete, as well as any return to operation after service work in accordance with the duties of the responsible organisation (see chap. 8 “Servicing / Maintenance”), may be carried out by the responsible organisation's own authorised specialist personnel. -
Page 47: Establish Standby Mode
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx 6.1.2 Establish Standby Mode 6.1.2.1 Connect the Handle 1. Connecting the handle (on the rear connection panel of the Complete) For this: Connect the luer connections [1] of the double tube to the connection... -
Page 48: Prepare The Devices Printer
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx 6.1.2.2 Prepare the Devices Printer 1. Open printer compartment [1] For this: Unlock Cover [1] by pressing the blue button [2]. Cover opens upwards. 2. Remove the guide rollers (with paper residue if necessary) [3] upwards. -
Page 49: Calibrate Spirostik Complete
• The seperate IFU Calibration Flow Sensor • This IFU - chap. 7.4 “Calibrating Spirostik Complete“ To ensure that the Spirostik Complete is ready for operation, please read: • This IFU - chap. 3.3 “Operation / Servicing and Maintenance“... - Page 50 Possible physical injury. Reason: Measurement error due to leakage caused by the incorrect assembly of components. Therefore: • Carefully observe the assembly instructions! Spirostik Complete could be damaged. Reason: Careless operation. Therefore: • Assure that all cables and tubes are connected carefully! Attention •...
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Page 51: Operating Instructions
Operating Instructions Spirostik Complete could be damaged. Reason: Penetrating liquid. Uncleanliness. External exposure. Therefore: • Do not use any liquids near the Spirostik Complete! • Do not expose Spirostik Complete or the entire system to dust or other contamination! •... -
Page 52: Establish Operational Readiness
Establish operational readiness As soon as the medical power supply is connected to the Spirostik Complete, the device can be put into standby mode using the power button on the back of the device. The device will be ready for operation. - Page 53 3 sec PC starts with a short delay. Windows interface including symbol for BLUE CHERRY® appears. Spirostik Complete is ready for use. Status LED on the back of the device lights up green; LED standby button white.
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Page 54: Inserting The Flow Sensor
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx Inserting the Flow Sensor 1. Insert Spiraflow [2] into the handle [1]. For this: Align the Spiraflow so that the interrupted guide rib [2a] and the nose on the handle are on the same side the pressure tapping holes [2b] show in the direction of the handle. -
Page 55: Calibrating Spirostik Complete
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx Calibrating Spirostik Complete There are various processes to be carried out for Spirostik Complete in order to calibrate or validate the volume measurement. Insert the flow sensor as described in chap. 7.3 "Inserting the Flow Sensor". -
Page 56: Using Spirostik Complete / Carrying Out Measurements
Therefore: • While using Spirostik Complete, do not use any transmitting devices (e.g. mobile phones, portable phones, power lines …) within close proximity (< 30 cm) that exceed the immunity levels as specified in the EMC guidelines! •... -
Page 57: Removing The Flow Sensor
For this observe the applicable regulatory requirements for biologically hazardous materials! • Clean and disinfect Spirostik Complete and its reusable components as instructed by the manufacturer at regular intervals as specified! The combination of single use flow sensors and noseclips offers... -
Page 58: Establishing Energy Saving Mode / Standby Mode
Chap. 11.3.3 “Infectious / Contaminated Single Use Items” Establishing Energy Saving Mode / Standby Mode The Spirostik Complete is intended as a device for continuous operation. Therefore, observe the following: If Spirostik Complete remains connected to the power supply, it is recommended to select the energy-saving mode with the Windows menu for shutting down the PC. -
Page 59: Servicing / Maintenance
The expected service life of Spirostik Complete is 8 years. In its development, a great deal of value was placed on making the servicing of all device components as simple as possible. -
Page 60: Servicing / Maintenance By The User / Operator
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx Independent of this, the user / operator must carry out regular checks during day-to-day operation, see also the following chap. 8.2 “Servicing / Maintenance by the User / Operator”! Attention... - Page 61 If there are any damages, do not operate the system. The damaged parts must be replaced or repaired properly! Reason: Electric shock. Triggering malfunctions of Spirostik Complete. Unqualified user / operator can detect sources of failures too late or even cause them. Therefore: •...
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Page 62: Checking For Damage
Serial no.: xx|8|102|yyy and 2103xxxxx 8.2.1 Checking for Damage 8.2.1.1 General All parts of Spirostik Complete should be checked for visible mechanical damage (cracks, tears) each day. If damage is ascertained, the corresponding component must be replaced. For replacing components see: •... -
Page 63: Cleaning And Disinfection
All other touchable parts Weekly disinfection All parts of the Spirostik Complete can be cleaned of dirt with a soft cloth using a cleaning solution / weak soapy water. All parts of Spirostik Complete which come into contact, or could come into contact, with the patient must be treated with a surface disinfection. - Page 64 Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx When using a disinfectant that has not been tested and approved by the manufacturer, the following steps must be observed: • Preferably use agents that correspond in composition to the approved agents. The composition is available on data sheets, which we can provide on request.
- Page 65 For this observe the applicable regulatory requirements for biologically hazardous materials! • Clean and disinfect Spirostik Complete and its reusable components as instructed by the manufacturer at regular intervals as specified! Possible physical injury. Reason: Misinterpretation of obvious measuring errors (drift) caused by liquid in the tubes.
- Page 66 Follow the instructions on the concentration and dwell time stated by the cleanser and disinfectant manufacturer! • Do not place Spirostik Complete in the cleaning and disinfection solutions! The device contains electrical components that will be damaged by doing so! Attention Reason: Penetrating liquids into electronic components.
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Page 67: Fault Indication And Repair
Serial no.: xx|8|102|yyy and 2103xxxxx Fault Indication and Repair Simple errors which occur when using Spirostik Complete can be recognised quickly and rectified using the following table. If you cannot find the error in the table or the problem cannot be rectified using the method described, please contact your specialist retail partner. - Page 68 Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx For other error conditions and their correction, please refer to this IFU: • Chap. 4.1.2.1 "Display Status LED" • Chap. 4.1.2.2 “Display and LED Standby Button“ Page 68 Version: 7 | Release date: 14. July 2021...
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Page 69: Decommissioning / Disposal
Decommissioning / Disposal 11.1 Expected Service Life The expected service life of Spirostik Complete has been stated by the manufacturer as 8 years. This applies provided the operating conditions, the prescribed servicing intervals, taking into account and complying with all safety information such as is described in this IFU as well as other technical standard regulations are adhered to. -
Page 70: Infectious / Contaminated Single Use Items
In order to ensure environmentally friendly disposal, please contact the authorised specialist retail partner where you purchased Spirostik Complete and / or the accessories. 11.3.3 Infectious / Contaminated Single Use Items All contaminated items such as single use flow sensors and noseclips must be disposed of via hospital or medical practice waste. -
Page 71: Technical Specifications
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx Technical Specifications 12.1 Technical Data Medical device: Class IIa (in accordance with MDD 93 / 42 Council Directive of 14.6.1993 annex IX) Dimensions: (L) 330 mm x (W) 355 mm x (H) 75 mm... - Page 72 Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx Protection: Device: Electronic overvoltage, Undervoltage, Overcurrent protection, Internal 4.5 A fuse EMC: Group 1 / Class B Noise emission: < 80 dB(A) Flow measurement: Flow sensor: Spiraflow Measuring principle: Differential pressure Measuring range: ±16 l/s...
- Page 73 Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx Minimum PC system requirements: Processor: Quad-Core Intel Prozessor max. 2.4 GHz RAM storage: 4 GB DDR-3 Hard drive storage: 128 GB SSD Monitor: 10.1 inch screen diagonal 1280 x 800 pixel...
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Page 74: Installation And Operating Conditions
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx 12.2 Installation and Operating Conditions The following conditions supplement chap. 2.2 "Intended Use" and must be observed to maintain the properties of the Spirostik Complete guaranteed by the manufacturer and for the safety of the patient and operator. -
Page 75: Electrical Safety Concept
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx 12.3 Electrical Safety Concept 12.3.1 Spirostik Complete with Medical Device Cart and Isolation Transformer Version: 7 | Release date: 14. July 2021 Page 75... -
Page 76: Spirostik Complete Without Medical Device Cart And Without Isolation Transformer (Combined With Non-Medical Device(S))
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx 12.3.2 Spirostik Complete without Medical Device Cart and without Isolation Transformer (combined with Non-Medical Device(s)) Page 76 Version: 7 | Release date: 14. July 2021... -
Page 77: Spirostik Complete Without Medical Device Cart And Without Isolation Transformer
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx 12.3.3 Spirostik Complete without Medical Device Cart and without Isolation Transformer Version: 7 | Release date: 14. July 2021 Page 77... -
Page 78: Electromagnetic Compatibility / Emc Guidelines
Guidelines and manufacturer’s declaration – electromagnetic emissions The Spirostik Complete is determined for operation in an electromagnetic environment as specified below. The user / operator of the Spirostik Complete should ensure that it is operated in this environment. Measurement of Compliance Electromagnetic environment –... -
Page 79: Interference Resistance For All Me Systems Guideline And Manufacturer Declaration
Guidelines and manufacturer’s declaration – electromagnetic interference immunity The Spirostik Complete is determined for operation in an electromagnetic environment as specified below. The user / operator of the Spirostik Complete should ensure that it is operated in this environment. Measurement of IEC 60601 –... -
Page 80: Interference Resistance For Non-Life-Supporting Me Systems Guideline And Manufacturer Declaration
Guidelines and manufacturer’s declaration – electromagnetic interference immunity The Spirostik Complete is determined for operation in an electromagnetic environment as specified below. The user / operator of the Spirostik Complete should ensure that it is operated in this environment. Measurement of... - Page 81 If the measured field strength at the site where the Spirostik Complete is used exceeds the abovementioned compliance levels, the Spirostik Complete should be observed to demonstrate its intended function.
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Page 82: Recommended Safety Distances For Non-Life-Supporting Me Systems
The Spirostik Complete is determined for operation in an electromagnetic environment in which the RF disturbances are controlled. The user / operator of the Spirostik Complete may help to avoid electromagnetic interference by keeping the minimum distance between portable and... -
Page 83: Safety Of Product And Material
DIN EN ISO 10993-1:2017- 04 "Biological evaluation of medical devices" (biocompatibility). Spirostik Complete is a class IIa active medical device. Conformity with the underlying standards and directives is certified in the declaration of conformity which is included in the documentation accompanying the device. -
Page 84: Product Labeling / Type Label
/ EEC with identification of the involved notified body [12] Date of manufacture Safety symbols have been applied to the Spirostik Complete type label. It may not be changed or removed. If information should become unreadable, the type label should be replaced immediately. -
Page 85: Warranty And Service
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx Warranty and Service 15.1 General Conditions The manufacturer guarantees that the products you have purchased fulfill the listed technical data and that the medical devices are free from technical material and production defects. -
Page 86: Packaging And Shipping
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx 15.3 Packaging and Shipping To avoid damage during transport, devices must be sent along with the warranty claim in the original packaging. This also applies for defective devices being repaired. -
Page 87: Authorised Specialist Retail Partner
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx Authorised Specialist Retail Partner You can reach your responsible specialist retail partner via a contact form of the manufacturer www.geratherm-respiratory.com/login/ See depositors Version: 7 | Release date: 14. July 2021... -
Page 88: Attachment - Declaration Of Conformity
Instructions for Use Spirostik Complete Serial no.: xx|8|102|yyy and 2103xxxxx Attachment – Declaration of Conformity The Spirostik Complete declaration of conformity is enclosed with each device by the manufacturer. Page 88 Version: 7 | Release date: 14. July 2021...
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