Related Manuals for Tyromotion TYMO G6
Summary of Contents for Tyromotion TYMO G6
- Page 1 TYMO® G6 INSTRUCTIONS FOR USE Issue date of instructions for use 2024-03-13, Rev. 3...
- Page 2 Contact information: Manufacturer: Tyromotion GmbH Bahnhofgürtel 59 8020 Graz AUSTRIA PHONE +43 316 908 909 +43 316 231123 9144 EMAIL office@tyromotion.com www.tyromotion.com SUPPORT support@tyromotion.com Distributor (Germany, Switzerland, USA): Tyromotion GmbH Bahnhofgürtel 59 8020 Graz AUSTRIA PHONE +43 316 908 909...
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Page 3: Table Of Contents
Table of contents Introduction Training concept Symbols 1.2.1 Symbols in the instructions for use 1.2.2 Symbols on TYMO® Content Intended use Warranty and legal disclaimer Technology Overview Area of application Clinical application Indications/Contraindications Safety 3.2.1 Safety concept 3.2.2 Residual risk TYMO®... - Page 4 Periodic check Lifetime Cleaning instructions 6.4.1 Disinfection 6.4.2 Cleaning process Repair Disposal EN-3...
- Page 5 Figure 1 Figure 2 < 180 kg < 180 kg < 396.8 lbs < 396.8 lbs Figure 3 Figure 4 Figure 5 Figure 6 EN-4...
- Page 6 Figure 7 Figure 8 Figure 9 EN-5...
- Page 7 Figure 10 EN-6...
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Page 8: Introduction
Introduction We appreciate your choice of a new product from Tyromotion GmbH. To fully benefit from the options offered by this product read these instructions for use and save it for future use. 1.1 Training concept TYMO® is a complex technical device. Users of TYMO® are required to complete a training course and read the user manual in order to ensure the safety of patients, users and the device itself. - Page 9 Do not discard with household waste CE mark Information about the manufacturer of TYMO®, including the manufacturer's full mailing address is displayed next to the factory symbol. Date of manufacture Serial number of the device Medical device The UKCA mark is a product label used for medical devices marketed in the United Kingdom (England, Wales, Scotland) and shows the conformity.
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Page 10: Content
The customer must submit all warranty claims to Tyromotion in written form within 60 days of the occurrence of the problem and before the expiry of the warranty. Tyromotion is exclusively obligated to repair, exchange or correct faulty or non-compliant parts at its own discretion in accordance with the warranty. - Page 11 Tyromotion has been informed about the possibility of such damages. Tyromotion 's liability for damages resulting from or in connection with this contract may not in any event exceed the purchasing price of the product.
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Page 12: Technology
Technology 2.1 Overview Type description: TYMO® Classification: TYMO® is an active, therapeutic class I medical device according to rule 13 of Medical Device Regulation (EU) 2017/745. Type of applied part: Type BF Protection against electric Internally powered medical device shock: Electromagnetic Class B device (CISPR 11) TYMO®... -
Page 13: Area Of Application
2.2 Area of application The product is for indoor use. TYMO® is classified as a medical electronic device and therefore subject specific precautionary measures relating electromagnetic compatibility (EMC). It is absolutely imperative to observe the stated indications for EMC. Portable and mobile HF communication devices may affect the TYMO®. - Page 14 Guidelines and MANUFACTURER‘s declaration – ELECTROMAGNETIC EMISSIONS TYMO® is designed for operation in an ELECTROMAGNETIC ENVIRONMENT as indicated below. The customer or user of TYMO® must ensure that it is used in such an environment. Interference emission Agreement ELECTROMAGNETIC measurements ENVIRONMENT –...
- Page 15 Electrical Fast ± 2 kV for power supply Mains power quality should ± 2 kV for power Transient/Burst lines be that of a typical supply lines IEC 61000-4-4 commercial or hospital ± 1 kV for environment. input/output lines Not applicable Surge ±...
- Page 16 Conducted RF �� = 0.58 √ �� IEC 61000-4-6 150 kHz to 80 MHz Radiated RF 10 V/m 10 V/m �� = 0.35 √ �� 80 MHz to 800 IEC 61000-4-3 80 MHz to 2.7 GHz �� = 0.7 √ �� 800 MHz to 2.5 where P is the maximum output power rating of the transmitter in watts (W)
- Page 17 Recommended separation distances between portable and mobile RF communications equipment and TYMO® TYMO® is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Users of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the device as recommended below, according to maximum output power of the communications equipment...
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Page 18: Clinical Application
FCC Statement Please take attention that changes or modification not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may... - Page 19 • Motor neuron diseases, e.g., amyotrophic lateral sclerosis (ALS) • Muscular dystrophies • Paralysis due to a herniated vertebral disc • Orthopedic events such as e.g., amputation, joint surgery, or joint replacement Absolute Contraindications: The device must not be used! •...
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Page 20: Safety
Please be aware that your patients may have other contraindications that are not listed here. In the case of questions or feedback, please contact Tyromotion GmbH (for contact data see start of the document). -
Page 21: Residual Risk
Tyromotion GmbH can provide a detailed risk analysis upon request. If you think that you or someone who used TYMO® has experienced an injury due to the use of TYMO®... -
Page 22: Installation Of The Software
TYMO® is connected to your PC with Bluetooth technology. To produce this connection, it is first necessary to connect the Bluetooth adapter included in the scope of delivery to your PC and to install it. If you have purchased a PC from Tyromotion this installation will already have been carried out. -
Page 23: Deactivate The Integrated Bluetooth Adapter
Bluetooth adapter (if available) in your PC. If you have purchased a PC from Tyromotion this deactivation has already been carried out. To deactivate the integrated Bluetooth adapter, go to the control panel and choose Device Manager. - Page 24 Therefore, do not use the TYMO Therapy plate after a fall; instead, ® immediately contact Tyromotion GmbH or the dealer from whom you bought the TYMO Therapy plate. ®...
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Page 25: Tymo® Rolling Element 1D And 2D
TYMO® Therapy plate. Please check the Rolling Elements for mechanical damage before each use. Do not use the Rolling Elements if there is any damage and contact Tyromotion GmbH or the dealer from whom you bought the TYMO ® Therapy plate. -
Page 26: Tymo® Rolling Element 2D
Depending on the direction in which the TYMO® should be tilted, the Rolling Element 1D must be properly mounted on the underside of the TYMO® Therapy plate. Figure 16: 1D – Mounting direction for Figure 17: 1D – Mounting direction for the tilt movement left/right the tilt movement forwards/backwards Do not try to tilt TYMO®... -
Page 27: Led Status Tymo
4.2.3 LED Status TYMO® Observe the LED display on the TYMO® Therapy plate. This provides information on the status of the TYMO® Therapy plate. LED-Display Meaning Necessary Action Connection with software okay, battery Charging of the battery Shining ORANGE level under 15% (section 4.2.4) No connection with software, battery Charging of the battery... -
Page 28: Hardware Configuration
• Use exclusively the power supply provided by Tyromotion GmbH for the recharging of the battery. • Do not dismantle, open or shred secondary cells or batteries. -
Page 29: Service Information
Malfunction: Resulting measure: • Covers shake • Further use is prohibited • Protective covers Covers missing • Contact Tyromotion GmbH • Covers damaged • • Further use is prohibited Rolling elements damaged Rolling Elements 1D and 2D • or broken Contact Tyromotion GmbH •... -
Page 30: Periodic Check
An interval of one year is defined by Tyromotion GmbH for carrying out the periodic tests. Periodic tests may only be carried out by service representatives. The operating company of the device must ensure that the test intervals imposed for the periodic test are complied with. - Page 31 The devices of Tyromotion GmbH must be cleaned and disinfected after delivery before the first and any further use on the patient. 6.4.1 Disinfection The product can be disinfected with a 70% disinfectant IPA solution. It is recommended to wipe off any residue and dirt from the product, using a cloth with warm water and a mild detergent/soap without chlorine and let it dry before disinfection.
- Page 32 Tyromotion GMBH Bahnhofgürtel 59 8020 Graz, Austria PHONE +43 316 908 909 EMAIL office@tyromotion.com www.tyromotion.com SUPPORT support@tyromotion.com EN-31...
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