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idiag STMedical Operating Manual

Respiratory therapy device
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Operating Manual
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  • Page 1 Operating Manual...
  • Page 2 Copyright © 2012, idiag. All rights reserved. No part of this publication may be reproduced without written agreement of idiag, CH-8320 Fehraltorf nor may it be stored in a data retrieval system or distributed in any kind. idiag, the idiag logo is a trademark of idiag and may be protected in certain countries.

  • Page 3: Table Of Contents

    List of chapters Information about the Operating Manual | 5 User | 5 Further applicable documents | 5 User information | 5 Symbols in this manual | 5 Symbols used on the ST Medical ® Important security advice | 7 Intended use / Indications | 7 Warning statements | 8 Parts | 9...
  • Page 4 Technical data | 31 Important therapy recommendations | 32 Operating, transport and storage conditions | 33 Problems and solutions | 34 Waste disposal | 34 Warranty | 35 Attachment | 36 1. Determining the Vital Capacity (VC) | 36 2. Determining the Maximum Breathing Capacity (MVV) | 36 3.

  • Page 5: Information About The Operating Manual

    Information about the Operating Manual User It is recommended that the use and maintenance of the ST Medical device is re- ® stricted to trained persons, who are completely familiar with the ST Medical device ® and along with this Operating Manual. Any repair or service should be performed by authorized personnel only.

  • Page 6: Symbols Used On The St Medical

    Symbols used on the ST Medical ® Attention, consult The device must not be disposed of in the accompanying same way as normal domestic waste. If documents. you wish to discard this product, please contact your local authorities or dealer and ask for the correct method of disposal.

  • Page 7: Important Security Advice

    Important security advice • Use the ST Medical after you have read and understood this ® Operating Manual. • Keep this manual with the ST Medical ® WARNING Intended use / Indications • ST Medical is intended to be used for the purpose of respiratory muscle therapy ®...

  • Page 8: Warning Statements

    • The medical expert is fully responsible for any kind of medical or therapeutical treatments. Therefore idiag declaims any kind of responsibility for medical or therapeutical treatments. • The user accepts all responsibly for his or her therapy. Idiag is not liable for any side effects following ST Medical therapy.

  • Page 9: Parts

    Parts You first need to assemble the respiratory components, following the directions on page 12. Mouthpiece Respiratory components Service port Base Station Connecting cable Breathing bag Handheld Device with Sensors Inhalation Red alarm lamp, stop therapy session (see page 20) Exhalation Indicator lights / Timing...

  • Page 10: Introduction

    Introduction The ST Medical is an ergonomic and handy respiratory therapy device. It has been ® developed in co-operation with the Federal Technical University of Zurich (ETH) and the Interstate College for technology of Buchs (NTB, Switzerland). For people with pulmonary diseases, snorers and their partners, the consistent use of ST Medical promises a great improvement of their quality of life.

  • Page 11: Indications

    Indications See “Intended use / Indications”, page 7 Contraindications • Age < 6 years • A doctor has recommended you avoid physical stress • During pregnancy • Acute illnesses of the respiratory system (e.g. colds, respiratory tract inflam- mation and pneumonia) •...

  • Page 12: Installation Of The Handheld Device

    Installation of the Handheld Device V-Tube* Handheld Device Valve Piston* Screw fastening with small opening Mouthpiece* Individual breathing bag* Screw fastening with large opening Mouth tube* *Respiratory components Clean the ST Medical before the first use in accordance with ® chapter ‚maintenance‘.

  • Page 13: Setup The Base Station

    Consult a doctor. Do not inhale vapor. Immediately remove any liquid from the unit with a damp cloth and dispose of the cloth. Idiag accepts no responsibility for injuries to customers, or damage to the device, caused by leaking or defective batteries.

  • Page 14: Switching The Unit On And Off / Function Check

    Switching the unit on and off / Function check Switching on The Base Station is switched on by pressing the Enter button until the unit switches on and all segments and lights are acti- vated. Press Enter to continue. Select person number will be displayed. select person: The Handheld Device is activated by connecting it to the Base Station.

  • Page 15: User Specific Adjustment

    User specific adjustment The Base Station can store user specific data of 4 different per- sons. Prior to your first therapy session you must determine and enter the volume of your breathing bag and your respiratory rate. The ST Medical needs these user specific data to provide you with ®...
  • Page 16 The Base Station now determines your personal respiratory rate- resp. volume 112 liter / min. volume per minute. If you do not change the calculated value, you may go back to the selection menu by pressing the ENTER button. If you want to change the established value, the program allows you to enter new values for bag volume and respiratory rate.

  • Page 17: Therapy With St Medical

    Therapy with ST Medical ® Prior to your first therapy session or after changing the settings: • have the settings determined and cleared by a medical profes- sional. WARNING • enter the volume of your breathing bag and your respiratory rate.

  • Page 18: Changing The Respiratory Rate During Therapy

    Start inhaling at the beep, the indicator lights now run from right to left. Inhale! The two green lights are helping you to syn- chronize your breathing: The lights are indicat- You are You are ing whether you are at the end of an inhalation inhaling exhaling or exhalation cycle.

  • Page 19: End Of Therapy Session / Storage Of Data

    If the valve piston does not move for more than 10-15 seconds, break! the display will indicate ‚break!‘. This may be caused by an interruption of therapy session, insufficient breathing (too light) or a falsely chosen breathing bag (too big). The ST Medical will ®...

  • Page 20: Error Messages

    (page 15). Cannot read or write date. Please return the device to your local OUT OF ORDER! dealer for repair work or directly to Idiag. This message appears after a program update and informs you therapy data that logbook and personal therapy data have been deleted.

  • Page 21: Logbook

    Logbook After a therapy session the data will be transferred to the log- book. The logbook can store up to 20 therapy sessions. More about storing data on page 19. You must switch off the device before calling in the therapy data of a different person.

  • Page 22: Maintenance

    Necessary repair work should only be carried out by Idiag or an authorized customer service center. Faulty compo- nents which may affect the safety of the ST Medical equipment ®...

  • Page 23: General Information Regarding Hygiene

    Maintenance, Cleansing, Disinfection, Sterilizing General information regarding hygiene The following chapters deal with the sanitary handling of the ST Medical ® • For hygienic reasons, we recommend using a personal mouthpiece and breathing bag or a personal user kid consist- ing of all respiratory components (definition see page 12).

  • Page 24: Hygiene Overview

    Hygiene overview Situation Base Station Respiratory Breathing bag components Handheld Device Mouthpiece Without: Screw fastenings • breathing bag • mouthpiece Before the first • Clean and disinfect Breathing bag: sterile packed • Clean and sterilize Mouthpiece: • Clean and disinfect •...

  • Page 25: Cleansing

    Maintenance, Cleansing Cleansing Interval • See table “Hygiene overview”, page 24 • Clean items before disinfecting and before sterilizing • Clean the ST Medical equipment whenever necessary ® Methods • Cleaning with soap and water • Handheld Device and Base Station: Wiping off the surfaces •...

  • Page 26: Disinfecting

    • Handheld Device and Base Station: Wipe the surfaces with a lint free cloth moistened with mild soap and water. • Rinse the respiratory components by hand. • Respiratory components – except for the breathing bag – may be cleaned in the dishwasher. •...
  • Page 27 • Use a disinfectant that does not contain substances harmful to health and that does not leave any residues. • Use a disinfectant suitable for plastic. CAUTION • Use a disinfectant that is compatible with the materials (respi- ratory components: PSU, polysulphone). •...
  • Page 28 Procedure • Disinfect Handheld Device, Base Station and connecting cables by wiping off the surfaces with a lint free cloth moist- ened with disinfectant. • Disinfect the respiratory components in a disinfection bath consulting the disinfectant instructions. • Rinse the breathing bag with the disinfectant. •...

  • Page 29: Sterilizing The Respiratory Components

    Maintenance, Sterilizing Sterilizing the respiratory components Interval • See table “Hygiene overview”, page 24 • Sterilize the respiratory components whenever necessary. Methods of Respiratory components can be sterilized by “Pressure Steam sterilization Sterilization” (Autoclaving) or by “Ethylene oxide gas”, see page 30 •...
  • Page 30 Method Temperature Pressure Duration Maximum number of applications Pressure 121 ºC 1,1 bar 20 min. Breathing bag, steam 250 ºF 16 psi mouthpiece: 100 sterilization (Autoclaving) Other respiratory components: Ethylene oxide gas sterilization Procedure • See “Ethylene oxide gas Sterilization” manual •...

  • Page 31: Technical Data

    Respiratory components: 1 year Breathing bag, Mouthpiece: daily use: 3 months, maximum 1 year Batteries 2 or 4 batteries Idiag recommends: Alkaline Batteries Base Station Size AA 1.5V Lifespan at 30 minutes therapy per day: approx. 3 months (4 batteries) approx.

  • Page 32: Important Therapy Recommendations

    Information regarding interference and interference avoidance: This equipment has been tested and found to comply with the limits for EMV and the limits for medical devices in IEC 601-1-2:1994. These limits are designed to provide reasonable protection against harmful interferences in a typical indoor installation. This equipment can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interferences to other devices in the vicinity.

  • Page 33: Operating, Transport And Storage Conditions

    Operating, transport and storage conditions General transport and storage conditions • The ST Medical registers data with highly sensitive precision electronics. Shock ® and excessive vibration can damage these parts. • Handle with care. Do not drop! • Do not expose to extreme temperatures and direct sunlight. •...

  • Page 34: Problems And Solutions

    Or: Temporarily remove all batteries and put them back in again. If problems continue to emerge, please contact your ST Medical ® retailer or Idiag. See cover for address. Waste disposal Protect the environment! When disposing of this ST Medical , do so in an environmentally ®...

  • Page 35: Warranty

    Terms of Warranty Idiag warrants this product to be free from defects in material and workmanship for a period of one (1) year from the date of its original retail purchase. Guaranty performance can only be produced, if the ST Medical is sent back in the ®...

  • Page 36: Attachment

    Attachment The formulas are only approximations and are only valid within the scope of application provided. Please see the therapy recommen- dations for further information (page 32). WARNING 1. Determining the Vital Capacity (VC) The vital capacity can be determined either though direct measurement or using the following formula.

  • Page 37: Electromagnetic Compatibility (Emc)

    Electromagnetic compatibility (EMC) (EMC), IEC 60601-1-2 ST Medical needs to be installed and put into service according to the EMC information stated as follows. ® Use of portable phones or other radio frequency (RF) emitting equipment near a ST Medical , may cause ®...
  • Page 38 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ST Medical is intended for use in the electromagnetic environment specified below. It is the responsi- ® bility of the customer or user to ensure that the ST Medical is used in such an environment. ®...
  • Page 39 Guidance and manufacturer’s declaration – electromagnetic immunity ST Medical is intended for use in the electromagnetic environment specified below. The customer or ® the user of the ST Medical should assure that it is used in such an environment. ® Immunity test IEC 60601 Compliance...
  • Page 40 Recommended separation distances between portable and mobile RF communications equipment and the ST Medical ® ST Medical is intended for use in an electromagnetic environment in which radiated RF disturbances ® are controlled. The customer or the user of the ST Medical can help prevent electromagnetic interfer- ®...

  • Page 41: Operating Scheme

    Operating scheme Master Sheet...

  • Page 43: St Medical ® Therapy Data Sheet

    ST Medical therapy data sheet ®...
  • Page 44 Headquarters Sales and Support: Switzerland: idiag AG, Mülistrasse 18 CH-8320 Fehraltorf Phone +41 (0)44 908 58 58 +41 (0)44 908 58 59 info@idiag.ch www.idiag.ch Germany: idiag GmbH, Schaubingerstrasse 7 D-79713 Bad Säckingen Phone +49 (0)7761 933 83 63 +49 (0)7761 933 83 62 info@idiag.de...

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