A-Star Lumina User manual

Lumina - User Manual

1. Basic information and tables
Page 3of 42 Issue date 02.09.2019 Version 10.0
Contents
1. INTRODUCTION .......................................................................................................................................................5
1.1 MANUFACTURER ............................................................................................................................................................. 5
1.2 RISK MANAGEMENT PROCESS .............................................................................................................................................. 5
2. INTENDED USE.........................................................................................................................................................6
2.1 INTENDED USERS.............................................................................................................................................................. 6
2.2 USER TRAINING ............................................................................................................................................................... 7
3. WARRANTY AND MANUFACTURER'S RESPONSIBILITY..............................................................................................8
4. OPERATIONAL SAFETY .............................................................................................................................................9
4.1 MAINS SUPPLY AND OPERATION MODE.................................................................................................................................. 9
4.2 STORAGE,OPERATION AND TRANSPORT CONDITIONS ................................................................................................................ 9
4.3 WARNINGS AND SAFETY NOTES ........................................................................................................................................ 9
4.4 EXPLOSION PROOF ENVIRONMENT...................................................................................................................................... 12
4.5 ELECTROMAGNETIC ENVIRONMENT .................................................................................................................................... 12
4.6 LABELS ........................................................................................................................................................................ 12
4.7 TECHNICAL SUPERVISION.................................................................................................................................................. 13
4.8 THERMAL PROTECTION .................................................................................................................................................... 13
4.9 DISPOSAL..................................................................................................................................................................... 13
5. DEVICE CONSTRUCTION.........................................................................................................................................15
5.1 GENERAL CHARACTERISTICS .............................................................................................................................................. 15
5.2 LAMP CONTROLLER......................................................................................................................................................... 17
5.2.1 Display............................................................................................................................................................ 17
5.2.2 Parameter change key ................................................................................................................................... 18
5.2.3 INCREASE and DECREASE keys ....................................................................................................................... 18
5.2.4 START / STOP key ........................................................................................................................................... 18
5.3 NAME PLATE ................................................................................................................................................................. 18
6. DEVICE INSTALLATION AND START-UP...................................................................................................................19
6.1 DEVICE INSTALLATION ..................................................................................................................................................... 19
6.2 ASSEMBLING –LAMP ON A STAND...................................................................................................................................... 19
6.3 ASSEMBLING –LAMP ON A TABLE STAND ............................................................................................................................. 21
6.4 FILTER AND BULB ASSEMBLY.............................................................................................................................................. 22
6.5 FIRST OPERATION ........................................................................................................................................................... 23
6.6 TRANSPORT POSITION –LAMP ON THE STAND ....................................................................................................................... 23
7. DEVICE OPERATION ............................................................................................................................................... 24
7.1 PATIENT PREPARATION AND TREATMENT PERFORMANCE ......................................................................................................... 24
7.1.1 General........................................................................................................................................................... 24
7.1.2 Infrared radiation therapy ............................................................................................................................. 24
7.2 SETTING THE LAMP ON A STAND......................................................................................................................................... 25
7.3 SETTING THE LAMP ON A TABLE STAND ................................................................................................................................ 26
7.4 LAMP CONFIGURATION CHANGE ........................................................................................................................................ 27
7.5 TREATMENT TIME SETTING ............................................................................................................................................... 29
7.6 BULB BRIGHTNESS LEVEL SETTING ....................................................................................................................................... 29
7.7 START AND END OF THE TREATMENT ................................................................................................................................... 30
8. DEFINITIONS AND PARAMETERS............................................................................................................................31
8.1 TREATMENT PARAMETERS ................................................................................................................................................ 31
8.2 INTERFACE ELEMENTS...................................................................................................................................................... 31
9. INDICATIONS AND CONTRAINDICATIONS............................................................................................................... 32
9.1 INDICATIONS ................................................................................................................................................................. 32
9.2 CONTRAINDICATIONS ...................................................................................................................................................... 32
9.2.1 Absolute ......................................................................................................................................................... 32
9.2.2 Irradiation limitations .................................................................................................................................... 32
9.3 POSSIBLE SIDE EFFECTS .................................................................................................................................................... 33
10. MAINTENANCE, CLEANING, DISINFECTION............................................................................................................. 34
10.1 REPLACEMENT OF THE BULB ........................................................................................................................................ 34

1. Basic information and tables
User Guide - Lumina Page 4of 42
10.2 FUSE REPLACEMENT .................................................................................................................................................. 35
10.3 CLEANING AND DISINFECTION –LAMP............................................................................................................................ 36
10.4 CLEANING AND DISINFECTION –ACCESSORIES .................................................................................................................. 36
10.5 TROUBLESHOOTING................................................................................................................................................... 37
11. SPECIFICATION AND ACCESSORIES.........................................................................................................................38
11.1 SPECIFICATION ......................................................................................................................................................... 38
11.2 EMC PARAMETERS ................................................................................................................................................... 39
11.3 STANDARD ACCESSORIES............................................................................................................................................. 40
11.4 OPTIONAL ACCESSORIES ............................................................................................................................................. 40
12. APPENDIX A. SYMBOL DESCRIPTION ......................................................................................................................41
Table of figures
Figure 4.1. Classification label sample...................................................................................................................................... 12
Figure 4.2. Warning label sample............................................................................................................................................. 13
Figure 5.1. General view of the Lumina lamp –stand construction......................................................................................... 15
Figure 5.2. General view of the Lumina lamp –table construction.......................................................................................... 15
Figure 5.3. Lamp tube............................................................................................................................................................... 16
Figure 5.4. View of the rear side of the lamp tube................................................................................................................... 16
Figure 5.5. Interface panel description..................................................................................................................................... 17
Figure 5.6. Parameter change key............................................................................................................................................ 18
Figure 5.7. Increase and decrease keys.................................................................................................................................... 18
Figure 5.8. START / STOP key ................................................................................................................................................... 18
Figure 6.1. Assembly of a stand to the base............................................................................................................................. 20
Figure 6.2. Assembly of a lamp tube to the stand.................................................................................................................... 20
Figure 6.3. Attachment of mains cable clips............................................................................................................................. 20
Figure 6.4. Correct position of the U-shaped holder mounted to the base ............................................................................. 21
Figure 6.5. Positioning of the bushing, U-shaped holder and knob.......................................................................................... 22
Figure 6.6. Assembly / disassembly of the bulb and filter........................................................................................................ 23
Figure 7.1. Setting the operation angle of the lamp tube. ....................................................................................................... 26
Figure 10.1. Filter and bulb replacement ................................................................................................................................. 35

1. Basic information and tables
Page 5of 42 Issue date 02.09.2019 Version 10.0
1. Introduction
Read this Guide carefully before starting the unit operation!
Follow the recommendations presented in this Guide! This manual applies to 5.0 version
and higher. Device version is located on the nameplate.
Light therapy Lumina lamp should be installed by the seller. The recipient has the right to insist on the product
operation training.
The unit may only be operated by qualified personnel or under supervision of such personnel!
WARNING: The device is intended for adult patients only. It is not intended for use in a home healthcare
environment.
Description of symbols used in this manual:
Read appropriate passage of this user guide, warnings or important information. Failure to
observe warnings can lead to injuries.
Important notices and information.
Following texts marked with this symbol facilitates device operation.
WARNING: No modification of this equipment is allowed!
1.1 Manufacturer
ASTAR Sp. z o.o.
Ul. Świt 33
43-382 Bielsko-Biała, Poland
www.astar.eu
1.2 Risk management process
The manufacturer conducts continuous risk management process referring to the device construction, its
intended use, method of operation and maintenance. Residual risks are presented in this manual in form of
information about precautions, contraindications and warnings.

2. Intended use
Page 6of 42 Issue date 02.09.2019 Version 10.0
2. Intended use
Lumina –phototherapy lamp is an active, non-invasive therapeutic device.
Lumina is intended to perform heating operations using thermal energy emitted by the bulb, which are aimed at
heating the skin and subcutaneous tissue covered by these operations. The required radiation characteristics are
achieved by application of a suitable type of filter. The intensity of heat exchange through radiation depends on
temperature of radiation source related to the rating of the applied bulb, length of light wave, distance and angle
of incidence as well as on circumstances accompanying the influence (e.g. influence of ventilation and/or air
conditioning in the treatment room). Treatments are performed in non-contact method.
Special structure of the device makes it easy to operate and the controller, which is built-in the lamp tube,
increase the comfort of operation.
The therapeutic lamp Lumina is used in physiotherapy rooms, sanatorium, and rehabilitation health service and
in beauty clinics.
Lamp application areas include:
•locomotor disorders,
•arthritis, spondylosis,
•chronic periarthritic inflammation, tendonitis,
•myalgia, contractions, post-traumatic complications,
•chronic neuritis, neuralgias,
•skin disorders, furuncles, sebaceous gland infection,
•chronic artery inflammations,
•acne,
•pathological muscle tension,
•acceleration of regeneration processes.
In addition, infrared radiation is used before stretching exercises, mobilizations, tractions, massages and
kinesitherapies. It can also be used as a preparation prior to treatments of electrostimulation or biofeedback, as
increased skin temperature boosts its conductivity.
A list of indications and contraindications is provided in section 9.
2.1 Intended users
The patient should not be the operator.
Users (operators) of the Lumina can be:
•specialists in the field of the infrared radiation therapy,
•physiotherapists specializing in the therapy of the musculoskeletal system,
•sports medicine specialists,
•aesthetic medicine specialists,
•trained personnel performing treatments under the supervision of the above-mentioned specialists.
The user should have:
•knowledge about the indications and contraindications for the use of the infrared radiation therapy,
•knowledge of the terminology and technical terms used in the manual (e.g. knowledge of units of physical
quantities),
•practical skills in performing therapeutic treatments using devices for therapy, resulting from education,
experience and training.

2. Intended use
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Physical and cognitive requirements of the operator:
•eyesight enabling to recognize elements of keyboard and display,
•hearing enabling to hear the patient's voice,
•reading comprehension that allows to read the instructions of use and information on the casing of the
device,
•two functional upper limbs that allow to perform treatments and other activities related to the operation
of the device (e.g. the bulb replacement),
•age in the range of admissible value of professional activity (depending on the regulations of the country
where the device is used).
2.2 User training
The Lumina lamp user has to be properly trained in the device safe and effective use, before starting the
operation. Training in the rules of operation can be carried out by representatives of the manufacturer or
seller, based on this user manual.
Recommended training positions:
•information about the intended use of the device,
•occupational safety information,
•information on the construction and method of the output signals generation,
•information on available settings and operation modes,
•instructions for use,
•indications and contraindications for the therapy,
•information on recommended maintenance, cleaning and disinfection,
•handling in the event of a technical malfunction.
Due to requirements of local law and regulations in different countries, additional training activities may be
required. The user should inform the seller about such requirements in order to receive complete information.

3. Warranty and manufacturer’s responsibility
User Guide - Lumina Page 8of 42
3. Warranty and manufacturer's responsibility
The manufacturer warrants the device to be free of faults for the period of time and conditions stated in
Warranty Certificate. The manufacturer also provides post-warranty service for a period of 10 years from
launching the unit onto the market. The warranty includes all material and workmanship faults.
The manufacturer undertakes to observe the warranty agreement, if the following conditions are met:
•all repairs, changes, extensions and calibrations of equipment are performed by manufacturer
or authorized service personnel
•the mains supply system in the treatment room meets requirements of standards in force,
•the unit is operated by qualified personnel, in compliance with instructions presented in this manual,
•the unit is operated in compliance with its intended use.
The warranty does not include consumables, such as mains cables, holders, fuses, filter glass as well as defects
or damages caused by:
•incorrect placement, installation or configuration of the device,
•misuse or non-compliance with the instructions given in the manual,
•improper or inadequate maintenance by the operator,
•improper use in accordance with the environmental conditions specified for the product,
•unauthorized opening of the lamp tube casing,
•manipulation and / or unauthorized regulation,
•use of non-original accessories.
The warranty for the infrared lamp emitter is granted on the terms given by the manufacturers of these elements.
You can find information on this on the infrared lamp emitter package.
The manufacturer is not liable in case of transmission of infection by equipment components.
The expected "life time" of the device is 10 years.
After elapse of 10 years from the date of introduction of device and accessories in the market the manufacturer
is not liable for device and accessories' faults or its consequences. After elapse of the expected “life time”of the
device the user bears the complete responsibility for the occurrence of medical incidents.
The manufacturer bears no responsibility for results of faulty installation, wrong diagnosis, wrong use of the
device and equipment, failure to observe instructions in user manual and performance of repairs by unauthorized
persons.
There are no parts in the device, except for fuses, an infrared radiator (bulb) and filters that the user is allowed
to change by themselves. No parts can be serviced or maintained when the device is in use with a patient.
On demand, the manufacturer makes available technical diagrams, parts lists, descriptions, instructions for
calibration or other helpful information to appropriately qualified user's technical staff to repair these parts of
unit, which are described by the manufacturer as a reparable.

4. Operational safety
Page 9of 42 Issue date 02.09.2019 Version 10.0
4. Operational safety
4.1 Mains supply and operation mode
The Lumina lamp is designed for supply from AC mains with rating 230 V

10%, 50/60 Hz. It is a medical device
under safety class I, type B. The unit may be used only in rooms, where the electric system is executed in
compliance with standards in force. The unit is intended for continuous operation. It is not necessary to switch
it off from the mains between particular treatment procedures.
The lamp is connected to the mains using the detachable power cord. The power supply cord is equipped with
a mains plug that isolates the device from the supply mains on all poles simultaneously.
Recommendations related to isolation the device from the supply mains:
•Do not position the device so that it is difficult to operate the disconnection of the device from the supply
mains.
•To isolate the device from the supply mains, hold the mains socket-outlet with one hand, grasp the mains
plug with second hand and disconnect it from the mains socket-outlet.
Disconnection from the mains takes place after:
•removing the mains cable plug from the mains power socket,
•removing the mains cable plug from the socket on the unit,
•switching the mains switch to the "0" position.
4.2 Storage, operation and transport conditions
The unit must be stored in closed rooms, where the atmosphere is free from vapors and caustic substances and:
•the temperature is maintained between +5°C and +45°C,
•relative humidity does not exceed 75%,
•atmospheric pressure value is between 700 and 1060 hPa (70 –106 kPa).
The unit is intended for operation under the following conditions:
•ambient temperature between +15°C to +30°C,
•relative humidity between 30% to 75%,
•atmospheric pressure between 700 to 1060 hPa (70 –106 kPa).
If further transport of the device is required, use the delivery packaging. Transport shall be performed with
covered transport means.
Recommended transport conditions:
•ambient temperature between -10°C to +45°C,
•humidity between 20% and 95%,
•atmospheric pressure between 700 to 1060 hPa (70 –106 kPa).
4.3 WARNINGS and safety notes
The Lumina lamp is designed and manufactured so that its use does not endanger the health and safety of
patients, users and third parties, as well as it ensures therapeutic benefits to patients, provided that it is
operated under appropriate conditions and according to its purpose.
General information:
•The unit may be only operated by qualified personnel in compliance with instructions presented further
in this manual.
•No modification of this equipment is allowed!

4. Operational safety
User Guide - Lumina Page 10 of 42
•The treatment station (bed, couch) shall be located away from other electric devices and water supply/
sewerage installation/ central heating system, so that it is impossible for the patient to touch any of them
during treatment procedure.
•Do not position the lamp so that it is difficult to operate the disconnection of the device from the supply
mains.
•The lamp shall only be used with filter installed! Filters are equipped with a protective mesh that protects
the patient from any possible injury as a result of broken filter glass or bulb.
•Do not remove warning signs and labels put by the manufacturer on the unit casing.
•Avoid exposing the lamp to atmospheric factors (e.g. direct sunlight).
•Damaged cables, filters and/or bulb shall be replaced immediately. Pay special attention to the casing
cracks, threadbare insulation and partially torn interconnecting cables.
•Prevent any fluid from penetrating inside the unit. In case of any fluid getting inside the unit, switch the
unit immediately off, disconnect from the mains and contact service to inspect the unit.
•It is recommended to pay attention to the work of the cooling fan, the unit should not be used, if incorrect
operation or its lack is stated.
•By any means do not cover the ventilation gaps. Do not insert any objects into vents. If the staff notice
that the ventilation holes are clogged with dust, clean them with a vacuum cleaner. This operation can
also be done by an authorized service center.
•It is forbidden to adjust the position of the lamp tube using the holder of the filter. For adjustment use
handles located on the sides of the lamp tube.
•It is forbidden to place other devices on the stand.
•According to the device labeling: pushing, sitting on the stand and stepping is prohibited.
•The stability of the stand should be provided. The stand wheels are equipped with brakes, which should
be locked during the treatment session. The table base should be placed on a flat, stable surface.
•The lamp can be moved with the table base without having to unscrew it. During transfer, it should be
held by the tube or U-shaped holder (possibly additionally by the base itself), not by the handles on the
front part.
•The unit may be only used with accessories, spare parts, which have been determined to be safe and
appropriate inspection bodies have not issued contraindications against their use.
•It is recommended to use bulbs:
▪manufactured by Philips – infrared lamp emitter R-125 IR375 CH 230V 375W or IR250CH 230V
250W, thread E27
▪manufactured by Śląska Fabryka Lamp Żarowych „Helios” – infrared lamp emitter R-125 E27,
230V 375W, thread E27
It is permissible to use other infrared radiators with the E27 threaded bulb provided that their rated
power does not exceed 450W due to the permissible parameters of the casing.
•Each serious incident concerned with the device should be reported to the manufacturer and competent
authority of the country, where the user or patient resides. Serious incident means any incident that
directly or indirectly led, might have led or might lead to any of the following:
▪the death of a patient, user or other person,
▪the temporary or permanent serious deterioration of a patient's, user's or other person's state of
health,
▪a serious public health threat.
Electromagnetic compatibility:
•It is recommended to use original accessories, spare parts and equipment of Astar. Use of accessories,
transducers and cables other than those specified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
•Use of the Lumina adjacent to or stacked with other equipment should be avoided because it could result
in improper operation. If such use is necessary, the Lumina and the other equipment should be observed
to verify that they are operating normally.
•Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the Lumina, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this equipment could
result.