GERATHERM Spirostik Blue Instructions For Use Manual
  1. Manuals
  2. Brands
  3. GERATHERM Manuals
  4. Medical Equipment
  5. Spirostik
  6. Instructions for use manual

GERATHERM Spirostik Blue Instructions For Use Manual

Hide thumbs Also See for Spirostik Blue:
Table of Contents

Advertisement

Quick Links

Download this manual
Spirostik Blue
Serial numbers: 2111xxxxx
Instructions for Use
Version: 7
Release date: 02. August 2021
Please read carefully and store in a place which is always accessible for future
consultation!

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the Spirostik Blue and is the answer not in the manual?

Questions and answers

Related Manuals for GERATHERM Spirostik Blue

Summary of Contents for GERATHERM Spirostik Blue

  • Page 1 Spirostik Blue Serial numbers: 2111xxxxx Instructions for Use Version: 7 Release date: 02. August 2021 Please read carefully and store in a place which is always accessible for future consultation!
  • Page 2 Filename: TDOSPB0050R7 Language: English Affected serial numbers: 2111xxxxx Software version: valid from 1.3.1 Geratherm® Respiratory GmbH Kasernenstraße 4 97688 Bad Kissingen, GERMANY Tel.: +49 971 7857043-0 Fax: +49 971 7857043-30 info@geratherm-respiratory.com 0494 www.geratherm-respiratory.com EUDAMED SRN: © Geratherm® Respiratory GmbH DE-MF-000006818...

  • Page 3: Table Of Contents

    Consumable Items / Auxiliary Materials ......... 25 Safety in Handling ..............28 General Safety at Work and Personnel Qualification ..... 29 The Technical State of Spirostik Blue and System Construction ... 30 Operation / Servicing and Maintenance ........32 Electromagnetic Compatibility (EMC) ..........34 Cleaning and Disinfection .............
  • Page 4 Operation ..................49 6.1.3 Complete Installation with BLUE CHERRY® ......... 50 6.1.4 Calibrate Spirostik Blue / Set up functional Operations ....51 Returning to Operation after Servicing / Cleaning Work ....52 Operating Instructions ............53 Checking for Worn Parts .............. 53 Preparing the Device for Operation ..........
  • Page 5 12.2 Installation and Operating Conditions ........... 81 12.3 Electrical Safety Concept .............. 82 12.3.1 Spirostik Blue with Medical Device Cart and Isolation Transformer 82 12.3.2 Spirostik Blue without Medical Device Cart and without Isolation Transformer .................. 83 12.4 Electromagnetic Compatibility / EMC Guidelines ......84 12.4.1...

  • 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 Blue, 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 Blue Serial no.: 2111xxxxx 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 this warning information may lead to faults or malfunctions of the Spirostik Blue or may indicate that something in its environment may be damaged. Indicates places in the IFU which are relevant to the current topic but do not present any danger, or which simplify your handling of the Spirostik Blue.

  • Page 9: Symbols

    Instructions for Use Spirostik Blue Serial no.: 2111xxxxx 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.: 2111xxxxx Symbol Explanation For single use only! This symbol does not refer to the Spirostik Blue 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 Blue Serial no.: 2111xxxxx 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.

  • Page 12: Copyright

    Instructions for Use Spirostik Blue Serial no.: 2111xxxxx 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 Blue Serial no.: 2111xxxxx Conditions of Use Any other use of Spirostik Blue which is not described in this IFU is deemed improper use. The responsible organisation of Spirostik Blue 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 Blue, 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 Blue Serial no.: 2111xxxxx 2.1.2 Contraindication and Side Effect 2.1.2.1 Contraindications 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 Blue Serial no.: 2111xxxxx 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

    Responsible Organisation is any natural or legal person who is responsible for the operation of the health institution where Spirostik Blue is used by their employees (users). User is a medically trained specialist who is familiar with spirometry...

  • Page 18: Intended Use

    Respiratory GmbH products via the universal software BLUE CHERRY® (see chap. 4.1.5 “System Construction and Electrical Safety”). In all cases, the Spirostik Blue 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 Blue is suitable for use in all institutions including those in residential areas and those which are directly connected to Attention the public supply network which also supplies buildings used for residential purposes.

  • Page 20: Original Spare Parts / Accessories

    Chap. 4.1.5 “System Construction and Electrical Safety” • The separate Ambistik IFU Component Description / name Supply scope in units Spirostik Blue, Case Dispos Reusa able  For safe and secure transport of Spirostik 452571 Blue.  For organised and...
  • Page 21 Instructions for Use Spirostik Blue Serial no.: 2111xxxxx Component Description / name Supply scope in units Spirostik Blue 356246 [old:40.070]  Wireless Spirometer using Bluetooth 2.0.  Simple to use roll-in handle, low resistance Blueflow flow sensor.  Automatic sleep mode and wake-up for long battery life.
  • Page 22 Instructions for Use Spirostik Blue Serial no.: 2111xxxxx Component Description / name Supply scope in units Blueflow Set, Reusable Dispos Reusa 860490 able [old:40.060]  Set of intelligent, reusable Blueflow and mouthpiece for use with Spirostik Blue.  Sensor electronic stores...
  • Page 23 Battery Charger 803841 [old:40.07002]  For 2 x AA batteries  Two rechargeable batteries 2100 mAh (AA HR6) included. Spirostik Blue Head 164930  Replacement head for Spirostik Blue. Dispos Reusa Drying Bellows able  For removal of residual moisture in flow sensor.

  • Page 24: Optional Expansions

    Instructions for Use Spirostik Blue Serial no.: 2111xxxxx 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 25: Consumable Items / Auxiliary Materials

    Instructions for Use Spirostik Blue Serial no.: 2111xxxxx Component Description / name Provocation 403680 [old:10.507]  For performing bronchial provocation tests with BLUE CHERRY® diagnostic platform.  Offers pre-defined and user configurable protocols with timers for testing and dosage administration.
  • Page 26 Instructions for Use Spirostik Blue Serial no.: 2111xxxxx Component Description / name 879996 Blueflow Set, Disposable [old:40.050]  Single use disposable flow sensor including mouthpiece and disposable noseclip.  Including sensor codes determined during production to ensure measurement quality and avoid frequent calibration.
  • Page 27 Instructions for Use Spirostik Blue Serial no.: 2111xxxxx Component Description / name For disinfection bath for flow sensor with low chloride concentration  InstruPlus (Dr. Deppe GmbH)  Bomix Plus (BODE Chemie GmbH)  Desinfektion N (ANTISEPTICA Dr. Hans- Joachim Molitor GmbH) ...

  • Page 28: Safety In Handling

    In spite of this, dangers of injury to users / operators, patients and third parties as well as damage to Spirostik Blue or other materials may occur if this is: •...

  • Page 29: General Safety At Work And Personnel Qualification

    Always comply with general national regulations on accident prevention! Instruct users / operators accordingly! • Safety and warning information on Spirostik Blue may not be altered or removed! Have missing or not readable information replaced immediately! • When working with auxiliary materials, always...

  • Page 30: The Technical State Of Spirostik Blue And System Construction

    Instructions for Use Spirostik Blue Serial no.: 2111xxxxx The Technical State of Spirostik Blue and System Construction Possible danger to life. Reason: Electric shock. Cross-contamination. Misdiagnosis caused by measurement error. Therefore: • Do not overstress Spirostik Blue! Use with care! •...
  • Page 31 Reason: Electric shock and / or misdiagnosis due to loss of electrical safety caused by exceeding the recommended maintenance schedule. Therefore: • Ensure that Spirostik Blue cannot fall down! Otherwise, the functionality must be checked properly before putting into operation! • Regularly check the specified maintenance schedule! •...

  • Page 32: Operation / Servicing And Maintenance

    Therefore: • In principle, observe chap. 12 “Technical Specifications”! • Do not operate Spirostik Blue if there are flammable or explosive gases in the room! • Do not operate Spirostik Blue near the magnetic field of an MRT system! Possible danger to life.
  • Page 33 Instructions for Use Spirostik Blue Serial no.: 2111xxxxx Reason: Disregard a contraindication. Misdiagnosis caused by measurement error. Cross-contamination. For this: Observe the general medical principles! Therefore: • Inform yourself and observe the respective contraindications before each test! • When carrying out tests, observe the content of the applicable guidelines and recommendations (e.g.

  • Page 34: Electromagnetic Compatibility (Emc)

    Therefore: • While using Spirostik Blue, 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 35: Structure And General Function Of Spirostik Blue

    LED status display (see also chap. 4.1.3 Blueflow flow sensor (see also chap. 4.1.4) Replaceable Spirostik Blue head (see also chap. 4.1.2) Type label (see also chap. 14) Locking pins for head (see also chap. 8.2.2.2) Battery compartment with cover (see also chap. 6.1.2) Bluetooth dongle (see also chap.

  • Page 36: Replaceable Head

    Instructions for Use Spirostik Blue Serial no.: 2111xxxxx 4.1.2 Replaceable Head Spirostik Blue head Latch for positioning flow sensor (for rolling down movement) Sealing Adapter (holes for pressure measurement) Release Lever (to lock / unlock the flow sensor) Page 36...

  • Page 37: Led Status Display

    Explanation Action NONE Switching on Spirostik Blue Device in sleep mode (LED off) (see chap. 7.3 “Switching Spirostik Blue On / Off”) No / empty Insert / replace the (rechargeable) batteries (rechargeable) atteries (see chap. 6.1.2 “Inserting the (rechargeable) Batteries and preparing the Device for Operation”)

  • Page 38: Flow Sensor

    Therefore: Attention • Exactly follow instructions for cleaning, disinfection and calibration! The heart of the Spirostik Blue is the Blueflow flow sensor. The Blueflow is available in two versions: • As a disposable version ( 879996), recognisable by the material colour "white”.

  • Page 39: System Construction And Electrical Safety

    Serial no.: 2111xxxxx 4.1.5 System Construction and Electrical Safety Spirostik Blue is operated with its own power supply (accumulators) and, along with the computer where the application software is installed, forms a medical electrical system (ME system). The following instructions serve to allow the safe construction of such a system, while taking into account the Spirostik Blue electrical safety concepts.
  • 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 Blue or complete system contrary to the respective manufacturer's specification! Reason: Electric shock. Therefore: •...
  • Page 41 Reason: Ignorance of safety instructions. Therefore: • The assembler of a system must provide the user / operator with all separate IFU applicable for the complete system! Spirostik Blue could be damaged. Reason: Electrostatic discharges. Therefore: • Preferably no floor made of synthetic material! Attention •...

  • Page 42: Bluetooth / Computer / Printer Data Connection

    Spirostik Blue Serial no.: 2111xxxxx 4.1.5.1 Bluetooth / Computer / Printer Data Connection The data connection between Spirostik Blue and the computer is wireless and occurs via a Bluetooth interface. For this, a validated Bluetooth dongle has been supplied with your product from the manufacturer.

  • Page 43: Power Supply

    Attention Blue is not being used for a longer period of time! Technical Protection Measures Spirostik Blue 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 chapter 8 “Servicing /...

  • Page 44: Software

    Spirostik Blue Serial no.: 2111xxxxx Software The measurement device (Spirostik Blue) is supplied with BLUE CHERRY® software. This serves to manage patient and examination data as well as carry out, depict, process and record measurements with the devices of the manufacturer.

  • Page 45: Transport, Storage And Assembly

    Unpacking and transport to the actual place of use are the responsibility of the responsible organisation. Storage The Spirostik Blue is a mobile, portable device that can be transported safely and securely in its case and stored and kept in an organised manner.
  • Page 46 Instructions for Use Spirostik Blue Serial no.: 2111xxxxx Spirostik Blue, Disposable Spirostik Blue Blueflow Set, Disposable (3x) Bluetooth dongle Battery charger Silicone adapter, small Accompanying documentation with BLUE CHERRY® Media Pack Spirostik Blue, Reusable Spirostik Blue [2a] Drying bellows [2b]...

  • Page 47: Assembly

    Safety” − Safe installation Assembly work is not required for the initial operation of Spirostik Blue, 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 48: Operation

    Spirostik Blue Serial no.: 2111xxxxx Operation The initial operation of Spirostik Blue, as well as any return to operation after service work in accordance with the duties of the responsible organisation (see chap. 8.2 “Servicing / Maintenance by the User / Operator”), may be carried out by the responsible organisation's own authorised specialist personnel.

  • Page 49: Inserting The (Rechargeable) Batteries And Preparing The Device For Operation

    (+ / -) [2]! (see also the marking on the battery compartment cover). Close the battery compartment cover until the snap lock [1a] clicks back into place Spirostik Blue is now ready for operation. Version: 7 | Release date: 02. August 2021 Page 49...

  • Page 50: Complete Installation With Blue Cherry

    Switch “Advanced” • Switch “Devices” in the menu • Switch “Bluetooth devices” in the sub-menu • Select “Spirostik Blue” in the list of devices • Place a cross by “Active” Page 50 Version: 7 | Release date: 02. August 2021...

  • Page 51: Calibrate Spirostik Blue / Set Up Functional Operations

    “Accept” button 6.1.4 Calibrate Spirostik Blue / Set up functional Operations Spirostik Blue is only completely ready to function after calibration and once the initial operation is complete. For details on conducting the calibration, please consult: •...

  • Page 52: Returning To Operation After Servicing / Cleaning Work

    / user is authorised. Servicing work here also includes the necessary checks which are necessary if Spirostik Blue should fall down. Before measurements can be carried out again using Spirostik Blue, all components must be connected with each other /...

  • Page 53: Operating Instructions

    Do not expose Spirostik Blue or the complete system Attention to dust or other unclean substances! • Do not drop any objects on Spirostik Blue! Do not lay any objects on it! Never push foreign objects into the housing! Checking for Worn Parts The Spirostik Blue should be checked for defective wearing parts each day before beginning treatments.

  • Page 54: Preparing The Device For Operation

    Chap. 6.1.2 ff “Inserting the (rechargeable) Batteries and preparing the Device for Operation” Switching Spirostik Blue On / Off As soon as the Spirostik Blue is supplied with power (batteries / accumulators inserted), it is switched on and is initially in standby mode.
  • Page 55 Serial no.: 2111xxxxx To remove the (rechargeable) batteries, please read: • Chap. 6.1.2 “Inserting the (rechargeable) Batteries and preparing the Device for Operation” Spirostik Blue could be damaged. Reason: Leaking battery fluid. Therefore: • Remove the (rechargeable) batteries when Spirostik Attention Blue is not being used for a longer period of time! Version: 7 | Release date: 02.

  • Page 56: Inserting The Flow Sensor

    Instructions for Use Spirostik Blue Serial no.: 2111xxxxx Inserting the Flow Sensor 1. a). Attach the mouthpiece [1] to the flow sensor [2]. For this: Orient the mouthpiece [1] in such a way that the arrow symbols on the mouthpiece [1a] and on the flow sensor [2a] sit on top of one another.
  • Page 57 Instructions for Use Spirostik Blue Serial no.: 2111xxxxx Orient the mouthpiece [1] to the LED status display [6] direction place the flow sensor [2b] onto the latch [4] of the head of the handle. 3. Fold the flow sensor in a rolling...

  • Page 58: Calibrating Spirostik Blue

    Spirostik Blue Serial no.: 2111xxxxx Calibrating Spirostik Blue There are various processes to be carried out for Spirostik Blue in order to calibrate or validate the volume measurement. Insert the flow sensor as described in chap. 7.4 "Inserting the Flow Sensor". Connect the calibration pump to the flow sensor (with the end opposite the mouthpiece).

  • Page 59: Using Spirostik Blue / Carrying Out Measurements

    Serial no.: 2111xxxxx Using Spirostik Blue / Carrying Out Measurements For further information see: • The separate IFU Spirometry − Use of Spirostik Blue and carrying out of measurements. • The separate IFU BLUE CHERRY® − General operation of the software and carrying out of measurements.
  • Page 60 No stacking of devices on top of each other and no close arrangement. Observe the installation and operating conditions from the manufacturer! • Check the correct function of the Spirostik Blue! Reason: Electric shock. Therefore: • Ensure that the users or third party persons do...

  • Page 61: Removing The Flow Sensor

    • Observe regulations on wearing personal protective equipment (PPE)! • Clean and disinfect Spirostik Blue and its reusable components as instructed by the manufacturer at regular intervals as specified! The combination of single use flow sensors and noseclips offers the highest degree of patient safety from cross contamination only if all contaminated parts are replaced and disposed of after the examination.
  • Page 62 Instructions for Use Spirostik Blue Serial no.: 2111xxxxx The removal and insertion procedure are the same for both versions. To do this, proceed as follows: 1. Unlock the flow sensor using the release lever [1] 2. Turn / fold the flow sensor in a rolling...

  • Page 63: Servicing / Maintenance

    The expected service life of Spirostik Blue 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 64: Servicing / Maintenance By The User / Operator

    Servicing / Maintenance by the User / Operator Attention “ ”! Servicing / Maintenance by the User / Operator In order to ensure a flawless operation of Spirostik Blue over its whole service life, regular servicing and repairs, if applicable, are required. Interval Servicing work...

  • Page 65: Charging The Rechargeable Batteries

    Spirostik Blue Serial no.: 2111xxxxx Possible danger to life. Reason: Electric shock. Triggering malfunctions of Spirostik Blue. Unqualified user / operator can detect sources of failures too late or even cause them. Therefore: • All maintenance and servicing work may only...

  • Page 66: Checking For Damage

    Serial no.: 2111xxxxx 8.2.2 Checking for Damage 8.2.2.1 General All parts of Spirostik Blue 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 67 1. Remove the old head [1]. For this: Pull out the locking pins [2] on both sides of the Spirostik Blue using a sharp object for example a paper clip [2a]. Remove the head [1] from the handle with an upwards movement along the guide rail [1a].

  • Page 68: Cleaning And Disinfection

    The devices of the manufacturer were designed in such a way that minimal effort is required for cleaning and disinfection. This is why just a few tasks are necessary to keep Spirostik Blue functional and clean. Cleaning and disinfection may cause discolouration of the components, but without impairing their function.

  • Page 69: Disinfection

    Instructions for Use Spirostik Blue Serial no.: 2111xxxxx Disinfection 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 70 • Follow the instructions on the concentration and dwell time stated by the cleanser and disinfectant manufacturer! • Do not place Spirostik Blue in the cleaning and disinfection solutions! Attention • The device contains electrical components that will be damaged by doing so! •...

  • Page 71: Spirostik Blue

    9.2.1 Spirostik Blue All parts of the Spirostik Blue can be cleaned of dirt with a soft cloth using a cleaning solution / weak soapy water. All parts of Spirostik Blue which come into contact, or could come into contact, with the patient must be treated with a surface disinfection.
  • Page 72 Instructions for Use Spirostik Blue Serial no.: 2111xxxxx 1. Separate the flow sensor [1] and mouthpiece [2] by pulling them apart. 2. Remove any visible contamination with a soft cloth using a cleaning solution / weak soapy water, rinse under running water.

  • Page 73: Drying Bellows

    Instructions for Use Spirostik Blue Serial no.: 2111xxxxx residual moisture from being sucked in. • Repeat the previous steps at the second hole for pressure measurement. 6. Visual inspection No contamination and residues of cleaning agents and disinfectant must be visible.

  • Page 74: Fault Indication And Repair

    Spirostik Blue Serial no.: 2111xxxxx Fault Indication and Repair Simple errors which occur when using Spirostik Blue 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 75 LED flashes blue and Check that BLUE CHERRY® has started then goes off again Check that the Spirostik Blue is set up in BLUE CHERRY® (see chap. 6.1.3 “Complete Installation with BLUE CHERRY®”) Check that the Bluetooth dongle is connected correctly (see chap.

  • Page 76: Decommissioning / Disposal

    Decommissioning / Disposal 11.1 Expected Service Life The expected service life of Spirostik Blue 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 77: Spirostik Blue

    Disinfect all impurified / contaminated components of Spirostik Blue before disposal! Spirostik Blue is an active medical device and is thus subject to the WEEE directive 2012 / 19 / EU and the German law on electrical and electronic devices (ElektroG) for the disposal for old electrical items.

  • Page 78: Infectious / Contaminated Single Use Items

    Instructions for Use Spirostik Blue Serial no.: 2111xxxxx 11.3.5 Infectious / Contaminated Single Use Items All contaminated items such as single use flow sensors, filters, mouthpieces and noseclips must be disposed of via hospital or practice waste. Possible severe physical injuries.

  • Page 79: Technical Specifications

    Instructions for Use Spirostik Blue Serial no.: 2111xxxxx 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) 210 mm x (W) 130 mm x (H) 50 mm...
  • Page 80 Instructions for Use Spirostik Blue Serial no.: 2111xxxxx Accuracy: ±3% or 50 ml/s Volume: Measuring range: 0 – 20 l Accuracy: ±3% or 50 ml Surface temperature: Normal operation: < 43 °C First error: < 60 °C Storage / Transport: min.

  • Page 81: Installation And Operating Conditions

    Instructions for Use Spirostik Blue Serial no.: 2111xxxxx 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 Blue guaranteed by the manufacturer and for the safety of the patient and operator.

  • Page 82: Electrical Safety Concept

    Instructions for Use Spirostik Blue Serial no.: 2111xxxxx 12.3 Electrical Safety Concept 12.3.1 Spirostik Blue with Medical Device Cart and Isolation Transformer Page 82 Version: 7 | Release date: 02. August 2021...

  • Page 83: Spirostik Blue Without Medical Device Cart And Without Isolation Transformer

    Instructions for Use Spirostik Blue Serial no.: 2111xxxxx 12.3.2 Spirostik Blue without Medical Device Cart and without Isolation Transformer Version: 7 | Release date: 02. August 2021 Page 83...

  • Page 84: Electromagnetic Compatibility / Emc Guidelines

    Guidelines and manufacturer’s declaration – electromagnetic emissions The Spirostik Blue is determined for operation in an electromagnetic environment as specified below. The user / operator of the Spirostik Blue should ensure that it is operated in this environment. Measurement of Compliance Electromagnetic environment –...

  • Page 85: Interference Resistance For All Me Systems Guideline And Manufacturer Declaration

    Guidelines and manufacturer’s declaration – electromagnetic interference immunity The Spirostik Blue is determined for operation in an electromagnetic environment as specified below. The user / operator of the Spirostik Blue should ensure that it is operated in this environment. Measurement of...

  • Page 86: Interference Resistance For Non-Life-Supporting Me Systems Guideline And Manufacturer Declaration

    Guidelines and manufacturer’s declaration – electromagnetic interference immunity The Spirostik Blue is determined for operation in an electromagnetic environment as specified below. The user / operator of the Spirostik Blue should ensure that it is operated in this environment. Measurement IEC 60601 –...
  • Page 87 If the measured field strength at the site where the Spirostik Blue is used exceeds the abovementioned compliance levels, the Spirostik Blue should be observed to demonstrate its intended function. If unusual performance characteristics are observed, additional measures may be required, such as a change in orientation or in location of the Spirostik Blue.

  • Page 88: Recommended Safety Distances For Non-Life-Supporting Me Systems

    The Spirostik Blue is determined for operation in an electromagnetic environment in which the RF disturbances are controlled. The user / operator of the Spirostik Blue may help to avoid electromagnetic interference by keeping the minimum distance between portable and mobile RF...

  • Page 89: Safety Of Product And Material

    DIN EN ISO 10993-1:2017- 04 "Biological evaluation of medical devices" (biocompatibility). Spirostik Blue 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 90: Product Labeling / Type Label

    Instructions for Use Spirostik Blue Serial no.: 2111xxxxx Product Labeling / Type Label The type label can be found on the handle of the Spirostik Blue. • See chap. 4.1.1 “Overview” point [6]. For more information about the symbols, please read: •...

  • Page 91: Warranty And Service

    Instructions for Use Spirostik Blue Serial no.: 2111xxxxx 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 92: Packaging And Shipping

    Instructions for Use Spirostik Blue Serial no.: 2111xxxxx 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. Transport damage arising from improper packing is the responsibility of the customer.

  • Page 93: Authorised Specialist Retail Partner

    Instructions for Use Spirostik Blue Serial no.: 2111xxxxx 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: 02. August 2021 Page 93...

  • Page 94: Attachment - Declaration Of Conformity

    Instructions for Use Spirostik Blue Serial no.: 2111xxxxx Attachment – Declaration of Conformity The Spirostik Blue declaration of conformity is enclosed with each device by the manufacturer. Page 94 Version: 7 | Release date: 02. August 2021...

This manual is also suitable for:

356246

Table of Contents