THERA-Trainer TT-SENS-14-01 Manual de usuario

FEEDBACK SENSOR INCL. TOUCH KEY

(MODEL: TT-SENS-14-01)

USER MANUAL

English translation of original user manual

Art. no.: A003-928_Rev 01

Last edited: CW40/2014

FEEDBACK SENSOR INCL. TOUCH KEY

USER MANUAL

Congratulations!

You've made a great choice by purchasing this feedback sensor incl. touch key. This innovative feedback

sensor incl. touch key delivers maximum performance –Made in Germany.

This user manual will help you get to know your feedback sensor incl. touch key better. It takes you

safely through the functions and use of your new feedback sensor incl. touch key, and also offers plenty

of tips and advice for getting the most out of it.

Before using the feedback sensor incl. touch key for the first time, please read chapter 2 "Safety and

dangers".

If you have any further questions or comments, your trained specialised dealer will be happy to help.

We hope you will enjoy keeping active with your feedback sensor incl. touch key.

FEEDBACK SENSOR INCL. TOUCH KEY

USER MANUAL

Art. no.: A003-928_Rev 01

Last edited: CW40/2014

1 USER GUIDE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

1.1 Warning notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.2 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

1.3

Symbols in the user manual . . . . . .

1.4 Symbols on the product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

2 SAFETY AND DANGERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

3 INTENDED USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3.1 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3.2 Biocompatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

4 FORSEEABLE MISUSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

4.1 Misuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

5 SCOPE OF DELIVERY AND EQUIPMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

5.1 Scope of delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

5.2 Basic equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

5.3 Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5.4 Removable parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6 OVERVIEW. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

7 STARTUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

7.1 Fixing the feedback sensor to the THERA-Trainer balo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

7.2 Fixing the feedback sensor to the THERA-Trainer coro . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7.3 Plugging in Bluetooth receiver for sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7.4 Switching on THERA-Trainer software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8 OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

8.1 Charging the battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

8.2 Switching on/off the feedback sensor incl. touch key. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

8.3 Establishing a connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

8.4 Error indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

9 TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

10 CLEANING AND DISINFECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

11 MAINTENANCE AND REPAIRS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

11.1 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

11.2 Further use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

12 TECHNICAL DATA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

13 DISPOSAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

14 NOTES ON ELECTROMAGNETIC COMPATIBILITY OF THE FEEDBACK SENSOR

INCL. TOUCH KEY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

14.1 Electromagnetic emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

14.2 Electromagnetic immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14.3 User Information acc. to FCC15.21 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14.4 Statement for Class B digital device acc.to FCC 15.105 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14.5 Statement acc. RSS Gen Issue 3, Sect. 7.1.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

15 WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Art. no.: A003-928_Rev 01

Last edited: CW40/2014

FEEDBACK SENSOR INCL. TOUCH KEY

USER MANUAL

1 USER GUIDE

The user manual and product are marked with a variety of symbols. These

symbols and their functions help you to use the product safely and efficiently

1.1 Warning notices

Warning categories

Warnings have different signal words depending on the type of danger:

Caution warns of the risk of material damage.

Warning warns of the risk of physical injury.

Danger warns of the risk of fatal injury.

Structure of warnings

Type and source of danger!

Action to avoid the danger.

Signal words

1.2 Notes

Information on the efficient use of the product.

1.3 Symbols in the user manual

Instructions

Structure of instructions:

►Instruction to do something.

Presentation of results if required.

Lists

Structure of non-numbered lists:

List level 1

–List level 2

Structure of numbered lists:

1. List level 1

2. List level 1

2.1 List level 2

2.2 List level 2

Note

Art. no.: A003-928_Rev 01

Last edited: CW40/2014

FEEDBACK SENSOR INCL. TOUCH KEY

USER MANUAL

1.4 Symbols on the product

User manual

Follow the user manual!

Manufacturer

Date of manufacture

Market launch in accordance with Medical

Devices Directive 93/42/EEC

Serial number

Disposal:

Do not dispose of the product in

household waste. Dispose of the product

in accordance with local regulations.

Type BF medical device

IP22

Protection against solid foreign objects

with a diameter greater than 12.5 mm.

Protection against dripping water when

the feedback sensor incl. touch key is

tilted up to 15° (only in combination with

the sensor holder).

Protect product from humidity.

This side up

Caution fragile

Temperature limit:

Between -25 °C (-13 °F) and +70 °C

(+158 °F)

Humidity limit:

Between 15 % and 93 % Rh

Air pressure limit:

Between 70 KPa and 106 KPa

Art. no.: A003-928_Rev 01

Last edited: CW40/2014

FEEDBACK SENSOR INCL. TOUCH KEY

USER MANUAL

2 SAFETY AND DANGERS

Observe the user manual.

If the user has a cardiac pacemaker, consult a doctor before the first training

session and observe emissions.

Do not use the feedback sensor incl. touch key in wet, humid or hot

environments.

Make sure that the feedback sensor incl. touch key does not get wet.

Only use the USB charger approved by the manufacturer.

Only use the USB charger for the feedback sensor with the correct supply

voltage.

Exclusively use the USB charging cable supplied by the manufacturer.

Exclusively charge the feedback sensor incl. touch key outside the immediate

patient surrounding (1.5 metres).

Ensure that the feedback sensor incl. touch key connected to the THERA-

Trainer software is clipped to the correct THERA-Trainer.

The maximum range of movement must not overstrain the user.

Only use the feedback sensor incl. touch key if in good and functional

condition.

In case of damage, malfunctions, etc., of the feedback sensor incl. touch

key, contact a trained dealer immediately.

Only use the feedback sensor incl. touch key if the USB charging cable is

undamaged and in proper working order.

Disinfect the feedback sensor incl. touch key before every training session.

Leave the feedback sensor incl. touch key at room temperature for 1 hour

before using it for the first time.

Have exclusively trained dealers done any repair work.

The battery in the feedback sensor incl. touch key may only be replaced by a

trained dealer.

The feedback sensor incl. touch key may only be opened by a trained dealer

and only modified after consultation with the manufacturer.

Faulty/damaged batteries are not suitable for transport. These must be

disposed of in accordance with national regulations.

The feedback sensor incl. touch key must not be returned to the manufacturer

with a faulty/damaged battery.

Art. no.: A003-928_Rev 01

Last edited: CW40/2014

FEEDBACK SENSOR INCL. TOUCH KEY

USER MANUAL

Note

3 INTENDED USE

The feedback sensor incl. touch key:

is used for wireless transmission of the inclination data to a control and

display unit. The biofeedback illustrations of appropriate THERA-Trainer

software are controlled on the basis of this inclination data.

The feedback sensor incl. touch key is used together with the suitable THERA-

Trainer software and a control and display unit to mobilise persons with limited

mobility with help of exercises.

Observe the indications of the THERA-Trainer and THERA-Trainer software being

used.

User

Persons who have been instructed by expert staff on how to use the

feedback sensor incl. touch key and are thus authorised to operate and

exercise with the feedback sensor incl. touch key.

The user is entirely responsible for the safe and correct use of the feedback

sensor incl. touch key.

Specialised staff

Persons who gained their skills and expertise by means of professional

training in the medical or medical-technical sector (e.g. doctors, therapists,

specialist dealers).

Persons who due to their professional experience and by means of

instruction/training by the manufacturer are able to assess safety-relevant

regulations and recognise potential risks in their field of work (e.g.

assistants).

To guarantee safe use of the feedback sensor incl. touch key, train expert

staff regularly.

3.1 Training

Before initial startup:

Have training

- By dealers, doctors or therapists trained by the manufacturer.

- Using this user manual.

Check with doctors or therapists whether training without supervision is

possible with the feedback sensor incl. touch key.

Have an assistant trained by dealers, doctors or therapists trained by the

manufacturer.

3.2 Biocompatibility

All components of the feedback sensor incl. touch key the user will touch when

using the unit as intended are designed to meet the biocompatibility requirements

of the applicable standards.

For any questions, contact a trained dealer.

Art. no.: A003-928_Rev 01

Last edited: CW40/2014

FEEDBACK SENSOR INCL. TOUCH KEY

USER MANUAL

4 FORSEEABLE MISUSE

The feedback sensor incl. touch key is not used for:

Diagnosis

Monitoring

Measuring

4.1 Misuse

Do not use the feedback sensor incl. touch key in:

Combination with other products emitting ionising radiation (e.g. radiation

therapy, nuclear medicine, etc.)

Rooms containing

–Explosive substances

–Oxygenated air

The presence of

–Flammable anaesthetics

–Volatile solvents

Devices not approved by the manufacturer.

Combination with wireless communications devices such as wireless home

network devices (WLAN, WiFi), mobile phones, cordless phones and their

base stations, or other hands-free kits, etc. These can influence the device

and should therefore be kept at a distance of 3.8 m.

5 SCOPE OF DELIVERY AND EQUIPMENT

The feedback sensor incl. touch key comes with individual options. This user

manual describes all options available for the feedback sensor incl. touch key.

Depending on the model, the user manual may include options not featured by

the feedback sensor incl. touch key. If the feedback sensor incl. touch key

features options are not described in the user manual, an appendix will be

included.

5.1 Scope of delivery

The delivery note contains all information about the scope of delivery.

5.2 Basic equipment

Basic equipment of the feedback sensor incl. touch key:

Feedback sensor incl. touch key

USB charging cable

Bluetooth receiver for sensors

Feedback sensor mounting kit for

- THERA-Trainer balo

- OR -

- THERA-Trainer coro

User manual Feedback sensor incl. touch key

Art. no.: A003-928_Rev 01

Last edited: CW40/2014

FEEDBACK SENSOR INCL. TOUCH KEY

USER MANUAL

Note

5.3 Options

Available option:

USB charger for feedback sensor

The feedback sensor incl. touch key can only be used in combination with the

suitable THERA-Trainer software, a control and display unit, and a Bluetooth

receiver for sensors.

5.4Removable parts

Name

Article no.

USB charging cable

A003-891

USB charger for

feedback sensor

A003-980

Bluetooth receiver for

sensors

A004-020

Art. no.: A003-928_Rev 01

Last edited: CW40/2014

FEEDBACK SENSOR INCL. TOUCH KEY

USER MANUAL

6 OVERVIEW

(1) Sensor orientation

(2) Touch key with touch pad

(3) Sensor detection (here feedback sensor incl. touch key Type A)

(4) Socket for USB charging cable

(5) Feedback sensor incl. touch key (applied part Type BF)

(6) Connection status indicator

(7) Activation/charge status indicator

(8) Sensor holder

4 3 2 1

5 6 7 8

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