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Summary of Contents for Tyromotion PONDUS M1612
- Page 1 PONDUS® - INSTRUCTIONS FOR USE Issue Date of User Guide: 2023-03-01, Rev. 1.0...
- Page 2 Contact information: Manufacturer: TYROMOTION GmbH Bahnhofgürtel 59 8020 Graz AUSTRIA PHONE +43 316 908 909 EMAIL office@tyromotion.com www.tyromotion.com SUPPORT support@tyromotion.com Distributor: R82 A/S Parallelvej 3 8751 Gedved Denmark PHONE +45 79 68 58 88 +45 75665192 EMAIL R82@etac.com etac.com Declaration of Conformity This product conforms to the requirements of the Medical Devices Regulation (EU) 2017/745.
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Page 3: Table Of Contents
Table of contents Introduction Symbols 1.1.1 Symbols in the instructions for use 1.1.2 Symbols on PONDUS® System 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 PONDUS® First steps 4.1.1 Charging PONDUS®... - Page 4 < 120 kg < 264.6 lbs...
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Page 7: Introduction
Introduction We appreciate your choice of a new product from TYROMOTION. To fully benefit from the options offered by this product please read these instructions for use and save it for future use. 1.1 Symbols 1.1.1 Symbols in the instructions for use Warnings: This symbol indicates a possible risk of injury to your own health or to the health of others. -
Page 8: System Content
Information about the manufacturer of PONDUS®, including the manufacturer's full mailing address is displayed next to the factory symbol. Date of manufacture Serial number of the device Medical device Upper and lower limit of temperature Indicates the upper and lower limit of temperature to which the medical device can be safely exposed. -
Page 9: Intended Use
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 10: Technology
TYROMOTION is in no way liable for indirect, incidental, specific or consequential damage or for punitive damage compensation including, among other things, the loss or absence of profits, yield, goodwill or usage, which the... -
Page 11: Area Of Application
Class B device (CISPR 11) Electromagnetic PONDUS® is suitable for usage in all establishments including compatibility: residential areas and areas that are directly connected to the PUBLIC SUPPLY GRID, which also supplies residential buildings. Country of origin: AUSTRIA Power supply voltage: 100 –... - Page 12 Interference emission Agreement ELECTROMAGNETIC measurements ENVIRONMENT – Guidelines HF emmissions according to Group 1 PONDUS® exclusively uses HF CISPR 11 energy internal FUNCTIONS. HF emissions are very low and unlikely to disrupt electronic devices within range. HF emissions Class B according to CISPR 11 PONDUS®...
- Page 13 Surge ± 1 kV differential ± 1 kV differential Mains power quality IEC 61000-4-5 mode mode should be that of a typical commercial or Not applicable Not applicable hospital environment. Voltage dips, short < 5 % U < 5 % U Mains power quality interruptions, (>...
- Page 14 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 IEC 61000-4-3 80 MHz to 2.7 GHz to 800 MHz �� = 0.7 √ �� 800 MHz to 2.5 GHz where P is the maximum output power rating of...
- Page 15 level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the PONDUS® system. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [4] V/m. Table 3: Guidelines and manufacturer‘s declaration –...
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Page 16: Clinical Application
Clinical Application 3.1 Indications/Contraindications In principle, for PONDUS® the same indications and contraindications apply as for the standing frames it is used in combination with. Knowledge of the contraindications is essential in order not to put the patient at risk. Before applying PONDUS®... -
Page 17: Safety
Caregiver • Every caregiver must have read the instructions for use prior to using PONDUS®. TYROMOTION GmbH rejects any liability for damages to persons or material if safety regulations and instructions relevant to the usage of PONDUS® are not observed! •... -
Page 18: Residual Risk
However, the probability of such injuries is very low, and the injuries should not be severe as long as all safety instructions in the present instructions for use are observed. TYROMOTION GmbH can provide a detailed risk analysis upon request. -
Page 19: Pondus
PONDUS® 4.1 First steps The time required for PONDUS® to warm/cool from the min./max. storage temperature between uses until the system is ready for its intended use at ambient temperature is hour. Please wait for this period of time before operating the unit. 4.1.1 Charging PONDUS®... -
Page 20: Shutdown Of Pondus
Start the PONDUS® App on your smartphone/tablet (figure 3). The App should automatically find the two plates. If not, drag down from the top in the list view. Select the two devices matching the colors of your plates. Now the LED button on the front side of the plates should change color to green and blue, indicating left and right and the PONDUS®... -
Page 21: Battery
PONDUS® plate is connected to a Solid GREEN smartphone/tablet PONDUS® plate is connected to a Solid BLUE smartphone/tablet PONDUS® plate is sending data to a Flashing GREEN connected smartphone/tablet PONDUS® plate is sending data to a Flashing BLUE connected smartphone/tablet Solid ORANGE PONDUS®... -
Page 22: Service Information
• Use exclusively the power supply provided by TYROMOTION GmbH for the recharging of the battery. Battery life: In use, the battery operating time is minimum 8 hours (when fully charged). Service information Maintenance of a medical device is wholly the responsibility of the owner of that device. -
Page 23: Lifetime
An interval of one year is defined by TYROMOTION GmbH for carrying out the periodic tests. 5.3 Lifetime The lifetime of this product in normal use is 5 years if all maintenance and servicing is carried out in accordance with the manufacturer’s instructions. -
Page 24: Repair
Directive 2012/19/EU on waste electrical and electronic equipment (WEEE-RL) and the respective national legislation. The product must be disposed of at the intended collection point or at a collection point approved for the recycling of waste electrical and electronic equipment. It can also be returned to TYROMOTION GmbH. - Page 25 TYROMOTION GmbH Bahnhofgürtel 59 8020 Graz, Austria PHONE +43 316 908 909 EMAIL office@tyromotion.com www.tyromotion.com SUPPORT support@tyromotion.com M1612...
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