Tyromotion PONDUS M1612 User manual

PONDUS® - INSTRUCTIONS FOR USE
Issue Date of User Guide: 2023-03-01, Rev. 1.0

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Contact information:
Manufacturer:
TYROMOTION GmbH
Bahnhofgürtel 59
8020 Graz
AUSTRIA
PHONE [phone]
EMAIL [email protected]
WEB www.tyromotion.com
SUPPORT [email protected]om
Distributor:
R82 A/S
Parallelvej 3
8751 Gedved
Denmark
PHONE [phone]
FAX [phone]
EMAIL [e-mail]
WEB etac.com
Declaration of Conformity
This product conforms to the requirements of the Medical
Devices Regulation (EU) 2017/745. The CE mark must be
removed when rebuilding the product or when using other
than original PONDUS® accessories.
PONDUS® is a registered trademark owned by R82 A/S.

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Table of contents
Introduction 6
1.1 Symbols 6
1.1.1 Symbols in the instructions for use 6
1.1.2 Symbols on PONDUS® 6
1.2 System content 7
1.3 Intended use 8
1.4 Warranty and legal disclaimer 8
Technology 9
2.1 Overview 9
2.2 Area of application 10
Clinical Application 15
3.1 Indications/Contraindications 15
3.2 Safety 16
3.2.1 Safety concept 16
3.2.2 Residual risk 17
PONDUS® 18
4.1 First steps 18
4.1.1 Charging PONDUS® 18
4.1.2 Installation PONDUS® App 18
4.2 Use of PONDUS® 18
4.3 Shutdown of PONDUS® 19
4.4 LED Status PONDUS® 19
4.5 Battery 20
Service information 21
5.1 Monthly functionality check 21
5.2 Periodic check 21
5.3 Lifetime 22
5.4 Cleaning instructions 22
5.4.1 Disinfection 22
5.4.2 Cleaning process 22
5.5 Repair 23
5.6 Disposal 23

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1
2
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< 120 kg
< 264.6 lbs

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4
5
6
7
8

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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. Be especially
mindful of these notices!
1.1.2 Symbols on PONDUS®
Follow the instructions for use
Applied part, type BF
Do not discard with household waste
CE mark
IP22
Protection class against foreign objects and water:
-2 means protection against penetration of solid
objects with a diameter ≥ 12,5 mm
-2 means protection against ingress of dripping water
(15° tilt)

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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.
Humidity limitation
Indicates the range of humidity to which the medical
device can be safely exposed.
Atmospheric pressure limitation
Indicates the range of atmospheric pressure to which the
medical device can be safely exposed.
1.2 System content
PONDUS® consists of the following components, included in the delivery:
•1x PONDUS® set (size 2, 3 or 4) consisting of two plates
•1x Software Application
•1x power supply
•1x USB charging cable

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•1x Instructions for use
•1x hook and loop adhesive pad set (for use with R82 Caribou and R82
Gazelle PS)
1.3 Intended use
PONDUS® is a medical device to support the positioning of the user in a standing
frame.
1.4 Warranty and legal disclaimer
TYROMOTION GmbH issues a warranty to the original system purchaser that the
system shall be free of material and qualitative processing defects for a period
of 12 months under normal usage conditions from the date of installation on
the owner's premises and that the system complies with the mechanical and
electrical specifications published by TYROMOTION. This warranty is granted
under the provision that the system is installed, operated and maintained in
accordance with the instructions for 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. TYROMOTION has no further
obligations to the owner in regard to these parts after the repair or exchange of
faulty or non-compliant parts. All repairs or maintenance work must be
performed by an authorized TYROMOTION service representative in accordance
with this warranty. The above mentioned warranty becomes null and void if
repairs, maintenance or other work is performed by third parties. Moreover,
problems resulting from accidents, improper use, incorrect application, storage
damage, negligence as well as system or component modifications are excluded
from the warranty.
The above mentioned warranty is granted in place of all other warranties, rights
or conditions, and the system is delivered "without deficiency warranty" apart
from the limited warranty. TYROMOTION and its third-party suppliers
specifically and unreservedly reject all other explicit or implicit warranties held
by the owner, his personnel and patients, customers, users and any third parties,
unreservedly including all warranties for marketability, applicability for a specific
purpose, non-infringement and any warranties resulting from performance
development, business trends or commercial customs. TYROMOTION and its

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third-party suppliers do not provide declarations or warranties for system
compliance with the owner's requirements or for functionality without
interruption, errors or deficiencies.
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
owner or third parties may incur or for damage to connected equipment, costs
for replacement products, installations, servicing, exchange elements or idle
time or for claims from patients, customers, visitors, the owner's employees or
other persons, regardless whether submitted within the context of a contractual
claim, due to unauthorized behavior, strict liability or imposed by law or
otherwise even when 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 system.
Some jurisdictions limit or exclude the extent of restrictions, the exclusion of
legal means, compensation or liability, such as liability for gross negligence or
willful misconduct according to or in the abovementioned extent or do not
permit the exclusion of implicit warranties. In such jurisdictions, the restriction
or exclusion of warranties, legal means, compensations or liabilities described
above may not be valid for the owner. Such restrictions or exclusions apply
according to the highest legally permitted extent even if they are not valid
according to the legally prohibited extent. The owner may also have other rights
that vary depending on the specific country or other jurisdictions.
Technology
2.1 Overview
Device name:
PONDUS®
Classification:
PONDUS® is a medical device class I according to medical
device regulation (EU) 2017/745, rule 13.
Type of applied part:
Typ BF
Protection against
electric shock:
Internally powered medical device

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Electromagnetic
compatibility:
Class B device (CISPR 11)
PONDUS® is suitable for usage in all establishments including
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 –240V alternating current
Supply frequency:
50/60Hz
Electricity/Power
consumption:
5V DC / 100mA charging
Battery:
Polymer-lithium-ion battery, 3.7V, 470mAh
The battery must not be replaced.
Radio transmission
frequency:
ISM Band (Bluetooth BLE)
Radiated transmission
power:
Max. 10mW
Operational area: 10 meters given uninterrupted view
between PONDUS® plates and used Tablet/Smartphone
Operating type:
Continuous operation
2.2 Area of application
The product is for indoor use.
PONDUS® is classified as a medical electronic device and
therefore subject to specific precautionary measures
relating to electromagnetic compatibility (EMC). It is
absolutely imperative to observe the stated indications for
EMC. Portable and mobile HF communication devices may
affect the PONDUS®.
Guidelines and MANUFACTURER‘s declaration – ELECTROMAGNETIC
EMISSIONS
PONDUS® is designed for operation in an ELECTROMAGNETIC ENVIRONMENT as indicated below.
The customer or user of PONDUS® must ensure that it is used in such an environment.

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Interference emission
measurements
Agreement
ELECTROMAGNETIC
ENVIRONMENT –
Guidelines
HF emmissions according to
CISPR 11
Group 1
PONDUS® exclusively uses HF
energy for its internal
FUNCTIONS. HF emissions are
very low and unlikely to
disrupt electronic devices
within range.
HF emissions
according to CISPR 11
Class B
PONDUS® is suitable for
usage in all establishments
including residential areas
and areas that are directly
connected to the PUBLIC
SUPPLY GRID, which also
supplies residential
buildings.
Harmonics emissions according
to IEC 61000-3-2
Not applicable
Emissions of voltage
fluctuations/flicker according to
IEC 61000-3-3
Not applicable
Table 1: Guidelines and manufacturer‘s declaration – electromagnetic emissions
Guidelines and MANUFACTURER‘s declaration – ELECTROMAGNETIC
IMMUNITY
PONDUS® is designed for operation in an ELECTROMAGNETIC ENVIRONMENT as indicated below.
The customer or user of PONDUS® must ensure that it is used in such an environment.
Immunity Test
IEC 60601-Test
Level
Compliance Level
ELECTROMAGNETIC
ENVIRONMENT -
Guidance
Electrostatic Discharge
(ESD)
IEC 61000-4-2
± 8 kV contact
± 2 kV, ± 4 kV, ± 8
kV, ± 15 kV air
± 8 kV contact
± 15 kV air
Floors should be
wood, concrete, or
ceramic tile. If floors
are covered with
synthetic material,
relative humidity
should be at least
30%.
Electrical Fast
Transient/Burst
IEC 61000-4-4
± 2 kV for power
supply lines
Not applicable
± 2 kV for power supply
lines
Not applicable
Mains power quality
should be that of a
typical commercial or
hospital
environment.

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Surge
IEC 61000-4-5
± 1 kV differential
mode
Not applicable
± 1 kV differential
mode
Not applicable
Mains power quality
should be that of a
typical commercial or
hospital
environment.
Voltage dips, short
interruptions,
and voltage variations on
power
supply input lines
IEC 61000-4-11
< 5 % UT
(> 95 % dip in UT)
für 0.5 cycles
70 % UT
(30 % dip in UT) for
25 cycles
< 5 % UT
(> 95 % dip in UT)
for 5 s
< 5 % UT
(> 95 dip in UT) for 0.5
cycles
70 % UT
(30 % dip in UT) for 25
cycles
< 5 % UT
(> 95 % dip in UT) for 5
s
Mains power quality
should be that of a
typical commercial or
hospital
environment.
Power Frequency
(50/60 Hz) Magnetic Field
IEC 61000-4-8
Not applicable
Not Applicable
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital
environment.
NOTE: UTis the AC mains voltage before application of the test level.
Table 2: Guidelines and manufacturer‘s declaration – electromagnetic immunity
Guidance and Manufacturer’s Declaration— ELECTROMAGNETIC
IMMUNITY
PONDUS® is designed for operation in an ELECTROMAGNETIC ENVIRONMENT as indicated below.
The customer or user of PONDUS® must ensure that it is used in such an environment.
Portable and mobile RF communications equipment should be used no closer to any part of the
device, including cables, than the recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
Immunity Test
IEC 60601-Test
Level
Compliance Level
ELECTROMAGNETIC
ENVIRONMENT -
Guidance
Recommended
Separation Distance:

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Conducted RF
IEC 61000-4-6
6 Vrms
150 kHz to 80 MHz
6 V
𝑑 = 0.58 √𝑃
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2.7 GHz
10 V/m
𝑑 = 0.35 √𝑃80 MHz
to 800 MHz
𝑑 = 0.7 √𝑃800 MHz to
2.5 GHz
where P is the maximum
output power rating of
the transmitter in watts
(W) according to the
transmitter
manufacturer and d is
the recommended
separation distance in
meters (m).
Field strengths from
fixed RF transmitters, as
determined by an
electromagnetic site
surveya, should be less
than the compliance
level in each frequency
range b.
Interference may occur
in the vicinity of
equipment marked with
the following symbol:
NOTES:
- At 80 MHz and 800 MHz, the higher frequency range applies.
- These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption
and reflection from structures, objects, and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the PONDUS® system is used exceeds the applicable RF compliance

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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.
b 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 – electromagnetic immunity
Recommended separation distances between portable and mobile RF
communications equipment and PONDUS®
PONDUS® 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.
Rated Maximum Output
Power of Transmitter
W
Separation Distance According to Frequency of Transmitter
150 kHz to 80 MHz
𝑑 = 0.58 √𝑃
80 MHz to 800
MHz
𝑑 = 0.35√𝑃
800 MHz to 2.5
GHz
𝑑 = 0.7√𝑃
0.01
0.058
0.035
0.07
0.1
0.18
0.11
0.22
1
0.58
0.35
0.70
10
1.83
1.11
2.21
100
5.80
3.50
7.00
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
NOTES:
- At 80 MHz and 800 MHz, the higher frequency range applies.
- These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
Table 4: Recommended separation distances between portable and mobile RF
communications equipment and PONDUS®

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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® in combination with a standing frame to a patient, check
carefully if one or more contraindications exist. Also, be aware that your patient
may have additional indications and/or contraindications that have not been
listed here but may be relevant. The following listings have no claim to
completeness.
Indications
PONDUS® can be used by children and adults with disabilities using a standing
frame. The target group for the PONDUS® is based on functional ability and
anthropometry. It is not based on a specific health condition or age.
The user is the person standing in the frame in which PONDUS® plates are
mounted. The caregiver is the person operating the frame and PONDUS®. Never
leave the user unattended in a standing frame. Ensure permanent supervision
by a caregiver. The use of the PONDUS® and standing frame will be discontinued
more times during the day where the user will be lying down or sitting in another
assistive device or a conventional product.
Contraindications
There are no known contraindications. However, you must familiarize yourself
with the contraindications of the specific standing frame model the PONDUS® is
used in combination with.
Precautions
Be aware of the height of the PONDUS® plates. When placed in the foot holds
of a standing frame, it positions the user approx. 20 mm higher, and thus the
mounted standing frame accessories should be adjusted accordingly to support
the user properly. Special attention should be given to the considerations about

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the configuration of the standing frame and the use of standing frame
accessories for users with limitation in their:
-sensory functions and the sensation of pain, consider extra checks of
the pressure caused by the support provided by the standing frame and
its accessories.
-movement function (e.g., experience involuntary movements), pay
special attention when using a standing frame
-ability to maintain a standing position, use the product with standing
frame accessories (e.g., chest or back support).
-ability to maintain the position of their head, consider using standing
frame accessories or to use a standing frame that provide support to
the positioning of the head.
3.2 Safety
3.2.1 Safety concept
In order to prevent problems with the use of the device the following
instructions for proper use are also to be adhered to.
Caregivers are obligated to familiarize themselves with these
safety instructions and avoid conditions that may lead to injuries
or damages.
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!
•Only use original accessories from the manufacturer that are supplied
in the system contents.
•The caregiver must take appropriate measures to stabilize the user
during use.
•PONDUS® must not be charged during use.
•If there is any doubt as to the continued safe use of PONDUS® or if any
parts should fail or become defective, stop using the product
immediately and contact TYROMOTION GmbH or your local dealer.

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•The cleaning instructions stated in these instructions for use must be
strictly observed.
Environment
•Do not use PONDUS® in combination with standing frames that have
not been recommended by TYROMOTION GmbH. Unforeseen risks
could arise for people and equipment.
PONDUS® may only be used in combination with the following standing
frames:
oR82 Meerkat
oR82 Rabbit Up
oR82 Toucan
oR82 Caribou
oR82 Gazelle PS
Product
•No modifications of PONDUS® are allowed.
•Always contact the manufacturer for repairs!
3.2.2 Residual risk
An unpredictable residual risk remains despite all safety precautions. In rare
cases, the user may experience minor pinching or crushing injuries even during
proper operation. 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.
If you think that you or someone who used PONDUS® has experienced an injury
due to the use of PONDUS® please report this to the manufacturer and to your
national health authority.

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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 one hour. Please wait
for this period of time before operating the unit.
4.1.1 Charging PONDUS®
The PONDUS® system is equipped with a rechargeable battery. Before using
PONDUS® for the first time, fully charge the system using the supplied USB cable
and power supply unit (figure 4). The charging time is 3 hours when the battery
is completely empty.
4.1.2 Installation PONDUS® App
Install the PONDUS® app directly from the respective app store or scan the QR
code (figure 2) using your smartphone or tablet.
4.2 Use of PONDUS®
To use PONDUS®, carry out the following steps:
1Switch on the two plates of the PONDUS® system by pushing the LED
button on the front panel of the plates (figure 3). They should now start
flashing yellow, which means they are in paring mode.
2Place the plates in the sandals provided on the standing frames. Make
sure that the plates are engaged in the designated indentations of the
sandals (figure 6). If you use PONDUS® in combination with the
standing frames R82 Gazelle PS or R82 Caribou, you can also use the
additional hook and loop adhesive pad set (figure 8).
3Now put the user on the plates and fix the feet in the sandals (figure
7).
4The plates must be paired to the PONDUS® App. For this, the Bluetooth
function of your smartphone or tablet must be activated. For a
successful Bluetooth connection, the plates must be positioned within
a radius of 10m (in the same room) from the smartphone/tablet.

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5Start the PONDUS® App on your smartphone/tablet (figure 3).
6The App should automatically find the two plates. If not, drag down
from the top in the list view.
7Select the two devices matching the colors of your plates.
8Now the LED button on the front side of the plates should change color
to green and blue, indicating left and right and the PONDUS® plates
(figure 3).
9The plates are now connected to the PONDUS® App and PONDUS® is
ready to use.
10 Follow the instructions in the PONDUS® App.
Error messages are displayed directly in the app and errors can be corrected
interactively. If necessary, restart the app and plates and follow the steps
described above again.
If the PONDUS® plates are not connected to the PONDUS® App, they switch off
automatically after 10 minutes.
4.3 Shutdown of PONDUS®
Follow these steps to shut down PONDUS®:
1Release the patient from the sandals of the standing frame.
2End the Bluetooth connection by closing the PONDUS® App.
3Take the plates out of the sandals and switch off the PONDUS® plates
by pushing the LED button on the front panel for at least 3 seconds
(figure 3).
4.4 LED Status PONDUS®
Observe the LED button on the front side of the plates (figure 3). This provides
information on the status of PONDUS®.
LED-Display
Meaning
Flashing YELLOW
Waiting for a connection
Solid COLOR
A smartphone/tablet was connected and set
a color for identification
Flashing in-between ORANGE
Battery below 10%