medolight Z4L Light Therapy Device Instruction Manual

medolight Z4L Light Therapy Device

Product Description

medolight Z4L is a device intended for exposure with LED light in the wavelength range of red and infrared light. medolight Z4L features an integrated matrix of 54 red LEDs (emitting light of 640 ± 30 nm wavelength) and 54 infrared LEDs (emitting infrared light of 880±30nm wavelength). The device is powered with a built-in rechargeable battery, which can be charged with the charger included in the set. The device uses a microprocessor to control the operating mode and exposure time, as well as the battery charge level.

Manufacturer’s data and service data

• ZEPTER International Poland Sp. z o.o., ul. Domaniewska 37, 02-672 Warsaw, Poland
• Please send your comments on the product to: medolight@zepter.com.pl

Intended use And Contents

Intended use

The medolight Z4L light therapy device is intended for use in:

• analgesic treatment with particular emphasis on muscular pains,
• treatment of local skin lesions in dermatology, including treatment of acne vulgaris and psoriasis,
• treatment of soft tissue inflammation,
• complementary treatment of certain ocular diseases, after consultation with the attending physician,
• physiotherapy and sports medicine, with particular emphasis on post-traumatic conditions of the musculoskeletal system,
• aesthetic medicine,
• degenerative changes in the joints,
• additional therapy for wound care,
• seasonal affective disorder (SAD),
• relieving stress and excessive tension.

Contents of the set

The set includes:

• medolight Z4L,
• YS10MB charger,
• cable for connecting the device with the charger,
• lanyard,
• user manual,
• guarantee card.

Description of symbols

Use guidance

• Use the device only under stationary conditions; do not use it while on means of transport.
• Do not use the device while the battery is charging, otherwise the housing may overheat.
• Before using medolight Z4L light therapy device, please consult your physician to determine whether this type of treatment is suitable for you or whether you require another medical treatment.
• Before using medolight Z4L, clean and disinfect the device and the area to be exposed to light.
• Relax and direct the light beam onto the area to be exposed to light from the distance of approximately 5 mm and try not to move the light beam during treatment, if possible. In case of large and problematic zones, expose one spot of the area at a time.
• Exposure can be interrupted at any time.
• The device will switch off by itself past the pre-set exposure time. After 1 minute of “inactivity” the device will switch to sleep mode, saving the last settings.
• The following table of preventing and correcting health disorders should be used as a guide for the methods of exposure according to your needs.

Contraindications

Contraindications and limitations for use of the medolight Z4L device:

• Patients with epilepsy should consult their physician before starting light treatment.
• Pregnant women should consult their physician before starting light treatment.
• Patients with certain thyroid conditions (as assessed by the attending physician).
• History of all skin cancers.
• Lupus erythematosus.
• Use of photosensitising drugs.
• Photosensitivity.
• Ophthalmic diseases, unless treatment is instituted with medical approval.
• Porphyria.

Safety information

Warnings and safety information

_ WARNING: _When using the device, observe safety rules for operating electrical equipment, in particular:

• Read the user manual carefully before operating the unit and follow the instructions contained in the manual. It is recommended that you complete a training with your vendor.
• Handle the device carefully: protect it against impacts, falls, moisture and high temperatures.
• Do not immerse the device or the charger in water or other liquids.
• Do not use the device with wet hands or in a damp environment (for instance while bathing).
• The device should not be exposed to direct sunlight or other weather conditions (such as rain).
• Do not use the device or the charger if the housing is damaged.
• Before connecting the device to the charger, check the condition of the connection cable. If the cable is damaged, do not use it in any way. Instead, notify the manufacturer or authorised service centre to have the cable replaced with a defect-free cable.
• The unit is a heat source; to ensure proper cooling, make sure that cooling vents in the housing are not obstructed.
• To charge the battery, use only the YS10MB charger supplied with medolight Z4L. Using a different charger may damage the device.
• Use the YS10MB charger only with medolight Z4L. Using it for other purposes may damage the charger.
• If necessary, use an approved electrical extension cord.
• After charging, replace the USB slot cover to protect the device from water droplets.
• Keep the device away from pets that may cause mechanical damage.
• To clean and decontaminate the device and the charger, first disconnect it from the power source and switch it off.
• Use extreme caution when charging the device – keep it out of reach of children. Be careful to avoid accidental strangulation of children or infants with the charger cable.
• Do not use the device while the battery is charging, otherwise the housing may overheat.

WARNING: Any serious incident involving the product must be notified to the manufacturer at medolight@zepter.com.pl and to the competent authority of the Member State of residence of the user or the patient.

• Do not open the housing of the device or the charger and do not repair it yourself.
• In case of malfunction, repair should be carried out only by a service centre authorised by the manufacturer.
• Do not place charger in a way that makes it difficult to disconnect it from the mains.
• Avoid using this device in close proximity to other devices or placing the device on or under other devices as this may cause it to malfunction. If this cannot be avoided, observe both devices for proper operation.
• Do not use, place or store the device near any equipment or devices that may cause potential interference or damage to the device: heat generating devices such as an iron, a heater, steam generators such as a humidifier, a kettle, electromagnetic exposure generators such as microwave ovens, Wi-Fi devices.
• Using accessories, cables or applicators other than those listed in this manual or provided with the product may cause malfunction of the device.

WARNING: The product must not be:

• Used in spaces where flammable gases or vapours of flammable substances are present.
• Exposed to weather conditions.
• Exposed to moisture and liquids.
• Exposed to fire and high temperatures.

WARNING: The following warnings must be strictly observed:

• Using controls or settings or performing procedures other than those specified in this manual may result in uncontrolled exposure to light.
• Do not point the light towards your eyes. If the face is to be exposed, close eyes and remove contact lenses.
• The treated area must be exposed from the distance of 5 mm.
• The device features a rechargeable battery that may be hazardous to the environment – dispose of only in the containers for waste batteries.
• If the battery is showing signs of wear indicated by shorter operating time after a full charge, contact the manufacturer or authorised service centre to have it replaced.

WARNING: Do not dispose of the battery in a fire, never incinerate or throw the battery in a fire. This may cause the battery to explode, which is very dangerous and prohibited.

Product specifications

Manufacturer and service centre details

• Address: ZEPTER International Poland Sp. z o.o.
• Country of origin:  ul. Domaniewska 37, 02-672 Warsaw Poland, European Union
• Website: www.zepter.com
  • www.medolight.info
• Power supply
  • internal battery: 3.7 V / 1800 mAh Li-poly
  • charger: YS10MB
  • charger rated supply voltage: 100-240 V, 50/60 Hz
  • charger rated output voltage: 5.4 V
  • power consumption with charger: 18 VA
• medolight Z4L power consumption: max 8W
• Typical charging time: 3 hours
• Operating time after charging the battery: up to 60 min
• Length of emitted light waves:
  • infrared light: 880 nm +/- 30 nm
  • red light: 640 nm +/- 30 nm
• Duration of the light pulse: pulse duration / interval / repeatability
  • Program 1: continuous light
  • Program 2: 0.05 s / 0.05 s / 100%
  • Program 3: 0.833 . 10-3 s / 0.833 . 10-3 s / 100%
  • Program 4: 0.166 . 10-3 s / 0.166 .  10-3 s / 100%
  • Program 5: 0.0625 .  10-3 s / 0.0625 . 10-3 s / 100%
• Light energy at 5 min: max 8 J/cm2
• Exposure time: do 25 min +/- 5%
• Permissible temperature range:
  • operation: +10°C ÷ +40°C
  • transport and storage between uses: -20°C ÷ +45°C
• Device dimensions (L/W/H): 130 x 71 x 42 mm
• Weight:
  • medolight Z4L: 200 g
  • YS10MB charger: 75 g
• Typical battery service life medolight Z4L: 3 years
• Typical YS10MB charger service life: 3 years

Product conforming to the following standards

• Safety: PN-EN 60601-1; EN 60601-1; IEC 60601-1, IEC 60601-2-57
• Electromagnetic compatibility: PN-EN 60601-1-2; EN 60601-1-2; IEC 60601-1-2

Electromagnetic compatibility

The EMC Declaration of conformity in accordance with EN 60601-1-2 is available on request at the manufacturer’s offices and at www.medolight.info/emc

medolight Z4L has been tested for conformity with EN 60601-1-2. medolight Z4L is classified according to EN 60601-1-2 as Class IIa in accordance with Rule 9. The light emitted by medolight Z4L is low-energy radiation of negligible potential harmfulness. Therefore, this device can be used both in hospitals and medical facilities as well as at home by an untrained user. medolight Z4L is intended for use in the environment described below. The user is responsible for ensuring that the environment in which the device is used fulfils the following requirements.

Conducted disturbance emission – disturbance voltage according to EN 55011:2012| Range 0.15–30 MHz
ESD resistance in accordance with PN-EN 61000-4-2:2011| Air -15 kV, +15 kV

Contact -8 kV, +8 kV

Resistance to electrical fast transients (BURSTS) according to PN-EN 61000-4-4:2013-05| Range 80 –2700 MHz

10 V/m

Resistance to electrical fast transients (BURSTS) according to PN-EN 61000-4-4:2013-05| 2 kV, 100 Hz
Impact resistance (SURGE) according to EN 61000-4-5:2014-10|
Resistance to conducted disturbances, induced by

radio-frequency fields according to PN-EN 61000-4-6:2014-04

| 0.15–80 MHz

3 Vrms

Immunity to voltage dips, short interruptions and voltage variations according to PN-EN 61000-4-11:2007|

Cleaning and disinfection

• Clean the product with a dry, soft cloth.
• Do not use abrasive substances and substances containing free chlorine and oxygen as they may damage the housing.
• For disinfection use appropriate disinfectants for medical devices and follow the disinfection instruction provided by the disinfectant manufacturer.
• The device and the housing should be disinfected before use.
• To clean and decontaminate the device and the charger, first disconnect it from the power source and switch it off.

Using the device

Switching the device on and off

• Before switching the device on for the first time, the battery must be charged for 3 hours – see – Battery charge level indicator (11.6).
• Use the ON/OFF button to switch the device on and off.

When the device is switched on, it starts running a test program – indicators 1-5 plus the Batt indicator light up in sequence. The device automatically sets the first exposure program and exposure time of 5 minutes (indicator 1 is on). At the same time, the Batt. indicator shows the battery charge level for 5 seconds. If none of the control buttons is pressed within 1 minute of switching the device on, the device will go to the standby mode – all indicators will be off, the device will remember the last setting. To switch it back to active mode, press one of these three buttons: TIME, MODE or START.

Selecting exposure time

Use the TIME button to select one of the five exposure times: 5, 10, 15, 20, 25 minutes. When the device is switched on with the ON/OFF button, it automatically selects the 5-minute exposure time. Whenever the TIME button is pressed, the exposure time is extended by 5 minutes, which is signalled by another indicator lighting up for 5 seconds. After 5 seconds or upon pressing the MODE button, the device automatically returns to indicating the selected exposure program.

Selecting exposure program

Use the MODE button to select one of the five exposure programs. When the device is switched on with the ON/OFF button, it automatically selects exposure program 1. Whenever the MODE button is pressed, the exposure program is changed, which is indicated by lighting up of the corresponding indicator.

Additional information:

When the device indicates the selected exposure program, the exposure time currently set can be checked by pressing the TIME button. Exposure time selection and Exposure program selection functions can be used interchangeably and modified until the START button is pressed. If the TIME button is pressed and held, the device will change exposure times automatically. Similarly, if the MODE button is pressed and held, the device will change exposure programs automatically.

Switching exposure on

• Exposure starts by pressing the START button.

Switching exposure off

• Exposure ends automatically once the selected exposure time has elapsed. 1 minute after the end of exposure, the device goes into standby mode.
• To interrupt exposure at any time, press the ON/OFF button and turn the device off.

Additional information

• Pressing the ON/OFF button clears the set program and exposure time. When the device is switched on again, it returns to the initial program 1 and time of 5 minutes.
• During exposure, the TIME, MODE and START buttons are inactive.
• The end of exposure is indicated by a sound signal.

Pressing each of the three control buttons: TIME, MODE, START, is also indicated by a sound signal. If none of the three buttons TIME, MODE, START is pressed within 1 minute of the end of exposure, the device will go to standby mode, saving the already selected settings in its memory. To return to active mode, retaining previous settings, press one of the three buttons: TIME, MODE, START. Pressing the ON/OFF button in standby will erase earlier settings and automatically set exposure program 1 and exposure time of 5 minutes.

PLEASE NOTE

• This device is a heat source.
• After each exposure using program 1, the device must be left to cool down (after 20 minutes of exposure using program 1, leave the device to cool down for about 15 minutes).

Battery charge level indicator

Before operating the device for the first time, the battery must be charged for 3 hours.

Charging the battery

The battery is charged by connecting the YS10MB charger to the slot in the device and then to the mains. The battery is fully charged after 3 hours of continuous charging. When charging the battery, the device remains active at all times and the charging process is controlled. The battery charge level is signalled by a few beeps and the Batt. diode lighting up green (until the charger is disconnected from the mains). Leaving the device connected to the charger for more than 3 hours is not a hazard. Charging is possible with the device either on or off. For a proper battery formation process, the battery must be charged and discharged at least three times.

The Batt. LED indicates the battery charge level in the three operating phases of the device:

When switched on:

• Batt. LED lights up green – the battery is charged, the device can be used without connecting the charger,
• Batt. LED lights up red – the battery is heavily discharged, it is recommended to connect the charger.

During exposure:

• Batt. LED is off – battery charged, device ready for exposure,
• Batt. LED flashes red – the battery is partly discharged, but exposure can be continued,
• Batt. LED lights up red and stays on – the battery is almost flat, exposure can be continued,
• Batt. LED lights up red and several beeps sound – exposure is interrupted and the device switches off, the battery is discharged, connect the charger and run a full 3-hour charging process.

While charging the battery:

• Batt. LED lights up red – battery discharged,
• Batt. LED turns green and a beep sounds – the battery is charged,
• When the charger is disconnected, the Batt. LED goes out.

The device can also be used for exposure while the battery is being charged, but since this will shorten battery life, we recommend against it.

NOTE

• If the battery is completely discharged, connecting the charger may not be immediately indicated. The indication may appear after a few minutes. This is a normal feature of the battery.
• Do not charge the battery during the treatment, otherwise the housing may become excessively hot.

Troubleshooting

at the power outlet.

Bad charger plug contact. Bad contact in the device port.

| Plug the charger into a working outlet. Remove the charger from the outlet and reinsert it, pressing it well.

Remove the USB plug from the device slot and reinsert it, pressing it well.

• If remedial measures are ineffective, turn the device off and return it for service.

Guarantee

2 years guarantee

The guarantee is granted for 2 years of the date of purchase shown in the invoice provided by the seller when the product is delivered. The guarantee does not affect the customer’s rights under national legislation or the customer’s rights under the sales contract. Detailed guarantee conditions can be found in the guarantee card delivered to the customer together with the product and the purchase invoice.

Operating and transport conditions

The product must not be:

• Used in spaces where flammable gases or vapours of flammable substances are present.
• Exposed to weather conditions.
• Exposed to moisture and liquids.
• Exposed to fire and high temperatures.

Weather conditions

• Ambient temperature during operation: + 10°C to + 40°C
• Ambient temperature – transport and storage when not used: – 20°C to + 45°C
• Moisture during transport and storage: 0-90% non-condensing
• Air pressure during transport and storage: 500 – 1060 hPa

Disposal of equipment

The following environmental information is valid for the European Union and other European countries with separate collection systems. The packaging and housing of the device and charger, as well as the user manual, are recyclable.

Disposal of waste batteries

• This product contains a rechargeable battery. This symbol indicates that the battery should not be disposed of with normal household waste. Instead, it should be handed to an appropriate collection point for recycling.
• The battery does not contain levels of mercury, cadmium or lead exceeding the provisions of Directive 2006/66/EC with subsequent amendments.
• For your own safety do not remove the battery from the product and contact authorised Zepter Service Centre only.
• Replacement of batteries should only be done by an authorised Zepter Service Centre, and never by the user.

Disposal of the device

This symbol means that within the European Union the product must be disposed of at an appropriate collection point. This applies to the product and all accessories marked with this symbol. Products marked in this way may not be disposed of with normal household waste but must be handed to a collection point for recycling of electrical and electronic equipment.

Disposal of packaging

• To dispose of the packaging, please make sure to follow the environmental regulations in force in your country.

Declaration of conformity

• medolight Z4L is a Class IIa medical device according to Rule 9 and conforms to the provisions of Directive (EU) MDD 93/42/EEC.
• This declaration is supported by an EC certificate issued by TÜV Rheinland LGA Products GmbH.
• The device is marked with the CE0197 mark and conforms to the applicable standards, directives and regulations. The Declaration of Conformity is available at www.medolight.info/CE

Contact

Zepter International Poland Sp. z 0.0.

• PL 02-672 Warszawa, Poland ul. Domaniewska 37
• www.zepter.com
• www.medolight.info

References

• medolight byBioptron – aparat do swiatłoterapii
• urpl.gov.pl
• Home - Zepter Shop

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