Gima VISTA WOOD LAMP User guide

USER MANUAL

VISTA

MAGNIFIER LAMP

ENG

VISTA LED HANDLE
VISTA LED PLUS

VISTA UV HANDLE H.F
VISTA PLUS H.F

F3P29

Rev. 01

20.06.2022

ENG

Dear user, we encourage you to read this manual carefully before using the product.

The manufacturer states that this product complies with Annex I (General safety and performance
requirements) of (EU) REGULATION 2017/745 on medical devices, amended and integrated.

This manual’s content may be modified in part or in whole by MISMAL without prior notice in
order to make changes and improvements.

MIMSAL has a Customer Support service available.

Your team:

MIMSAL TRADE S.L.

C/ Mollet, 17
Polígono Industrial Palou Nord
08401 – Granollers (Barcelona) SPAIN

Tel. [phone]

mimsal@mimsal com
www.mimsal.com

TABLE OF CONTENTS

1.Safety instructions 5

2. Brief description 6

3. Installation and supports 7

3.1 Trolley Stand 8

3.2 AH Table Clamp 9

3.3 Wall B Support 10

3.4 Rail Plus Bracket 11

3.5 Extension arm 12

4. Operation of the lighting unit 13

4.1 Check before each use 13

4.2 Operation of the lighting unit head 13

4.3 Measurement details 13

5. Safety functions 14

5.1 Voltage drop 14

5.2 Power cuts 14

5.3 Electrical malfunction 14

6. Cleaning/Disinfection 14

6.1 General safety instructions 14

6.2 Cleaning 14

6.3 Disinfection 15

7. Maintenance 15

7.1 Lighting unit support arms 15

7.2 Lighting unit head 16

7.3 Repairs 16

7.4 Adjustments 16

7.5 Troubleshooting 16

8. Recycling 16

9. Technical data 17

10. Electromagnetic Emissions 18

11. Warranty 20

12. Industrial and Intellectual Property 21

13. Confidentiality 21

14. Declaration of Conformity 22

15. Certificate ISO 9001 24

16. Certificate ISO 13485 25

ENG

3

SYMBOLS

INSTRUCTIONS

DECLARATION OF CONFORMITY

MEDICAL DEVICE

ITEM CODE

BATCH NUMBER

MANUFACTURING DATE

NAME AND ADDRESS OF THE MANUFACTURER

ELECTRONIC WASTE RECYCLING

ELECTRICAL INSULATION CLASS

Class II

MINIMUM DISTANCE TO THE ILLUMINATED OBJECT

AMBIENT TEMPERATURE

Shows the permitted ambient temperature of between -25°C and 70°C for transportation and
storage.

ENG

HUMIDITY

Shows the permitted humidity values of between 10% and 75% for transportation and storage.

SAFETY RULES

WARNING

Not doing so could result in serious or even fatal injuries.

CAUTION

Not doing so could result in minor to moderate injuries or damage.

NOTE | INFORMATION

Provides application tips and useful information.

FALLING OF THE LIGHTING UNIT

Warns about the sudden collapse of the support arm system if the maximum useful load is
exceeded.

TIPPING HAZARD

The brackets are only designed to support the weight of the head. If additional weight is added, the
unit may tip over, which could cause damage of varying degrees.

4

REFERENCE AND MODEL

REF MODEL UDI-DI

E051L VISTA LED HANDLE 8436562860462

E051PL VISTA LED PLUS 8436562860479

E051CAO012 VISTA PLUS H.F 8436562860028

E051LAT212 VISTA UV HANDLE H.F 8436562860035

1. SAFETY INSTRUCTIONS

Check the operating instructions when handling the device.

This lighting unit is a Class I medical device according to (EU) Regulation 2017/745 on
medical devices.

ENVIRONMENT

1. This device is not designed to be operated in potentially explosive areas!

2. Do not use it in oxygen-enriched areas!

3. Do not use it near flammable anesthetic gases!

4. Do not place it close to strong magnetic fields! e.g. Magnetic resonance systems.

5. Do not cover the top of the lamp head! Risk of overheating!

ENG

ELECTRONIC SAFETY

1. Only use the built-in power source unit!

2. The lighting unit does not include a fail-safe power source or an emergency battery!

3. In the event of a power cut, the lighting unit will shut off completely!

4. Short black-outs are possible in the event of external EMC interference!

5. To switch off the lamp completely, the power plug must be removed from the outlet or the
live outlet must be disabled using a separate switch.

MAINTENANCE AND RESPONSABILITY

1. Installation and electrical maintenance work must only be carried out by qualified personnel!

2. The manufacturer is not responsible for any damage caused by improper use!

3. The final user is responsible for the product’s installation and MIMSAL accepts no responsibility.

4. The manufacturer is responsible for the safety of the lamp only if repairs and modifications are
carried out by the manufacturer itself or by a company that ensures compliance with safety
rules, using original replacement parts!

Prior to each use, make sure that the lamp is in perfect technical condition.

5

2. BRIEF DESCRIPTION

INTENDED USERS

These operating instructions are intended for the health professionals who use, clean, and
disinfect MISMAL lighting units.

INTENDED USE

This lighting unit is intended for carrying out very meticulous work that requires a high level of
precision. It is suitable for use in hospitals, medical research, laboratories, clinics, etc.

INDICATION

The light is only intended to provide optimal visibility of the surface being examined and has no
diagnostic or therapeutic effect. The light is external to the body and the device never enters
into contact with patients.

CONTRAINDICATION

The products must not be used close to strong magnetic fields.
The device must not be used in oxygen-enriched environments or in close to flammable

anesthetic gases.

RESIDUAL RISKS – RISK IN THE EVENT OF DAMAGE TO THE LIGHTING UNIT

Protect the lighting unit from knocks. Collision with other objects could result in the failure of
the device and/or damage to the cover and the support arm system, causing parts to fall off.

The lighting unit does not include a fail-safe power source. A power cut will cause the device
to switch off.

Do not aim the light source directly at the eyes of the patient and/or operator.
Always properly protect the patient’s eyes.
Failing to comply with these precautions could cause blinding and damage to the retina.
Never place and/or hang any object on the lighting unit. If this precaution is not taken, the unit’s

position will be unstable and these objects could fall onto the work area.
Never hang the body weight of a person from the lighting unit. Failing to comply with this

precaution could damage the structure of the device.

ENG

INCIDENTS AND REPORTS

The user and/or the patient must notify MISMAL and the competent authority in the country if
any serious incident occurs whilst using the device.

In accordance with the Medical Devices Regulation (MDR), the competent authority must be
notified immediately.

6

3. INSTALLATION AND SUPPORTS

Before starting to install the device, check that the content is in good condition and that it has
not been damaged or degraded during transportation.

Claims will only be accepted if the vendor or the carrier is notified immediately. All claims must
be made in writing.

The goods always travel under the buyer’s responsibility and at the buyer’s risk.
Keep the original packaging in the event the product needs to be returned.

TYPES OF SUPPORT

The lighting unit may come with several different types of brackets, allowing the most suitable
one to be selected for its use.

All accessories must be assembled by an authorized installer.
Do not make any modifications to the product, other than those mentioned in this user manual.

MODEL SUPPORT

TROLLEY STAND Rolling base with 5 wheels

AH TABLE CLAMP Table clamp

WALL B SUPPORT Reinforced wall B bracket

RAIL PLUS BRACKET Bracket for mounting on an ICU rail

EXTENSION ARM Extension arm + Reinforced wall B bracket

* These accessories are only valid for VISTA LED PLUS and VISTA PLUS H.F.
* VISTA LED HANDLE and VISTA UV HANDLE H.F are hand-held versions.

ENG

7

3.1 TROLLEY STAND

REF MODEL DESCRIPTION

09651 TROLLEY STAND 8,8 Kg 8.8 Kg rolling base

Install the accessory without the lighting unit installed on it.
It is the customer’s responsibility to ensure that the surface that it is attached to is

secure and sufficiently strong.

Check regularly that the unit is still stable in order to avoid the possibility of the
lighting unit falling down.

The rolling base is only designed to support the weight of the lighting unit. If additional
weight is added, the unit may tip over and cause damage to the lighting unit and/or
injury to the user.

1. Installation and assembly

- Insert piece (2) totally into the base (3) and press down.

- Insert the legs with the wheels (4) through the base slot (3) until it completely fits, and if
necessary helping with a nylon hammer.

- Fit piece 5 into the interior leg slots (4) by pressing down.

- Put the screw (7) through the washer (6) and insert the screw into piece 5 to connect the set.

- Join the pole (1) directly with the screw (7) without
tightening the pole (1) with the piece (2) so as not to
damage the paint.

- Hold the pole (1) firmly and turn the screw (7) with a
wrench or a scanner until the whole set is tight.

- Luminaries fixation system (8). Allen number 2.

2. Technical characteristics

- Length of pole: 75 cm

- Total length: 92 cm

- Base diameter: 60 cm

- Wheel diameter: 50 mm

- Number of wheels: 5

- Number of brakes: 3

Allen n. 2

ENG

1u. 8,8 Kg

8

3.2 AH TABLE CLAMP

REF MODEL DESCRIPTION

B010190 AH TABLE CLAMP Table clamp

Install the accessory without the lighting unit installed on it.
It is the customer’s responsibility to ensure that the surface that it is attached to is

secure and sufficiently strong.

Check regularly that the unit is still stable in order to avoid the possibility of the
lighting unit falling down.

The bracket is only designed to support the weight of the lamp. If additional weight is
added, this may cause damage to the lighting unit and/or injury to the user.

Installation and assembly

- Use the handle to loosen the adjustment screw (1).

- Rest the base of the clamp on the surface of the table (2).

- Adjust the body of the clamp (3) until it is touching the edge of the table.

- Turn the handle (4) until the clamp and the table are firmly attached.

- Once the clamp is fixed and secure, position the lamp through the upper hole (5).

ENG

9

3.3 WALL B SUPPORT

REF MODEL DESCRIPTION

B0101800 WALL B SUPPORT Reinforced wall B bracket. 7 cm shaft-wall separation.

Install the accessory without the lighting unit installed on it.
It is the customer’s responsibility to ensure that the surface that it is attached to is

secure and sufficiently strong.

Check regularly that the unit is still stable in order to avoid the possibility of the
lighting unit falling down.

The bracket is only designed to support the weight of the lamp. If additional weight is
added, this may cause damage to the lighting unit and/or injury to the user.

Installation and assembly

- Check that the wall is sufficiently hard-wearing and flat.

- Use the bracket to mark the holes on the wall with the help of a pencil (1).

- Drill holes and put the plugs into the wall (1).

- Position the wall support, lining it up with the location of the holes (2).

- Tighten the screws until the assembly, the guide separator and the screw are firmly attached
(2).

- Once the support is fixed and secure, position the lamp through the upper hole (3).

ENG

10

3.4 RAIL PLUS BRACKET

REF MODEL DESCRIPTION

82026 RAIL PLUS BRACKET Bracket for mounting on an ICU rail.

Install the accessory without the lighting unit installed on it.
It is the customer’s responsibility to ensure that the surface that it is attached to is

secure and sufficiently strong.

Check regularly that the unit is still stable in order to avoid the possibility of the
lighting unit falling down.

The bracket is only designed to support the weight of the lamp. If additional weight is
added, this may cause damage to the lighting unit and/or injury to the user.

Installation and assembly

- Loosen the adjustment screw via the wing screw (1).

- Fit the upper part of the support to the rail (2).

- The interior body of the support needs to be touching the rail (2).

- Tighten the wing screw until the support and the rail are firmly attached (3).

- Once the support is fixed and secure, position the lamp through the upper hole (4).

ENG

11

3.5 EXTENSION ARM

REF MODEL DESCRIPTION

B0101S0 EXTENSION ARM

Install the accessory without the lighting unit installed on it.
It is the customer’s responsibility to ensure that the surface that it is attached to is

secure and sufficiently strong.

Check regularly that the unit is still stable in order to avoid the possibility of the
lighting unit falling down.

The bracket is only designed to support the weight of the lamp. If additional weight is
added, this may cause damage to the lighting unit and/or injury to the user.

Installation and assembly

- Check that the wall is sufficiently hard-wearing and flat.

- Use the bracket to mark the holes on the wall with the help of a pencil (1).

- Drill holes and put the plugs into the wall (1).

- Position the wall support, lining it up with the location of the holes (2).

- Tighten the screws until the assembly, the guide separator and the screw are firmly attached
(2).

- Once the wall bracket is fixed and secure, position the end of the arm in the upper hole of the
support (3).

- Insert the shaft of the luminaire into the hole located at the other end of the extension arm (4).

- Turn the extension arm’s side screw in order to secure the luminaire (5).

Extension arm including Wall B Bracket. Provides an

additional 40 cm, with horizontal rotation along both axes.

ENG

12

4. OPERATION OF THE LIGHTING UNIT

4.1 CHECK BEFORE EACH USE

1. Check if the unit is visibly deformed. If any deformities are detected, contact the Customer
Support Department immediately.

2. Make sure the lamp is in the required hygienic conditions for use.

3. Always check the correct operation of the whole unit before turning it on. The unit must
move in every degree of motion whilst verifying the main function and the control system.

Do not use the unit if there are any doubts about its electrical safety or static and
dynamic stability.

4.3 ARTICULATED ARMS MEASUREMENT DETAILS

Lighting unit with simple and ergonomic operation for intuitive handling.
For VISTA LED HANDLE and VISTA LED PLUS:

- Find the power switch.

- Select the switch position I (UV) | 0 (Off) | II (White)

- Move the arm position to get the desired distance and lighting.

For VISTA UV HANDLE H.F and VISTA PLUS H.F:

- Find the power switch.

- Select the switch position I (On) | 0 (Off).

- Move the arm position to get the desired distance and lighting.

4.3 MEASUREMENT DETAILS

ENG

PLUS VERSION

171 cm

92 cm

51 cm

1. Minimum length

2. Maximum height

3. Maximum length

4. Minimun height

51 cm

86 cm

113 cm

46 cm

14 cm 57 cm

HANDLE VERSION

205 mm

220 mm

45 mm

325 mm

120 mm

Ø 30 mm

13

5. SAFETY FUNCTIONS

5.1 VOLTAGE DROP

In the event of a network voltage drop, the light will automatically switch off.

5.2 POWER CUTS

In the event of a total power cut, the light will switch off. As soon as voltage
is reestablished on the network, it can be turned on again using the most recent
established parameters.

5.3 ELECTRICAL MALFUNCTION

NOTE: In the event of this error, please contact the technical service.

6. CLEANING / DISINFECTION

6.1 GENERAL SAFETY INSTRUCTIONS

1. Disconnect the unit from the network before disinfecting it.

2. Never use an aerosol cleaner and/or disinfectant.

3. Do not spray liquid into sockets or slits on the unit or allow liquid to get into them.

4. Apply the cleaner by wetting a cloth, never by applying it directly to the device.

ENG

WARNING: ELECTRICAL SHOCK

The lighting units may transmit electricity and must be handled carefully during
cleaning and disinfection.

6.2 CLEANING

SAFETY

Check the general safety instructions.

RECOMMENDED CLEANING

1. Use a mild soap solution as a cleaning agent.

2. Thoroughly clean the surfaces with a dampened cloth, adding a bit of mild soap solution if

necessary.

3. Finally, thoroughly dry the exterior surface with a clean soft cloth (anti-static if necessary).

WARNING: RISK OF INFECTION AND CONTAMINATION OF PATIENTS

Solvents could corrode the plastics. Strong acids, alkalies, and agents that contain
more than 60% alcohol could turn plastics brittle. Damaged parts could fall into open
wounds.

14

6.3 DISINFECTION

SAFETY

Check the general safety instructions.

DISINFECTION PROCESS

The disinfection process is done using a cloth. The hygiene guidelines and safety measures for
the disinfection processes to be used must be defined by the operator.

We recommend using MELISEPTOL disinfectant made by Braun Melsungen and/or “neoform
MED rapid” made by Dr. Weigert. Follow all of the protection measures. Respect the
manufacturer’s instructions and follow the hygiene guidelines.

Disinfect surfaces every working day! Disinfect all of the affected surfaces immediately
after any contamination by potentially infectious material (e.g.: blood, secretion or
excrement).

Contact your hygiene specialist to coordinate the disinfectant and the proper
procedures with your internal requirements! Always follow the internal disinfection
plan!

WARNING: HEALTH HAZARD

Disinfectants may contain harmful substances that could injure the skin or eyes or
damage respiratory organs if inhaled.

7. MAINTENANCE

Medical devices must undergo regular cycles of maintenance and review. This is fundamental
for complying with safety measures.

See the reference in the IEC 62353 standard.
The medical device’s manufacturer is responsible for defining the regular safety measures. The

operator is responsible for implementing these measures.

ENG

NOTE: Always disconnect the device from the power source before doing any
maintenance or inspection work to prevent the device from turning on involuntarily.

7.1 LIGHTING UNIT SUPPORT ARMS

All brackets must be checked by the operator for the following points:

• Every 6 months:

1. Deformations of the bracket system.

2. Cracks in plastic pieces.

3. Damage to the paint.

• Every year:

1. A detailed inspection of the bracket system, such as the clamping force of the spring arm,
the fastening of the bracket etc.

2. Extensive operational test, including the ease of movement of the joints.

3. Electrical safety tests.

15

WARNING: ELECTRICAL SHOCK

Disconnect the unit from the power source during the whole of the checking process.

7.2 LIGHTING UNIT HEAD

The following inspections/maintenance must be carried out:

1. Check for any possible anomalies, cracks, deformations in plastic pieces and seals.

2. Carry out electrical safety tests.

3. Extended operational test.

4. Damage to the paint.

7.3 REPAIRS

The following indications must be followed:

- The product may only be opened and repaired by the manufacturer. Contact the Customer
Support department if necessary.

- It is totally prohibited to modify the device in any way.

* (See Warranty Section).

7.4 ADJUSTMENTS

The product is sold fully calibrated and does not require any additional adjustments.
If the product becomes unstable over time and cannot maintain its position, please contact the

Customer Support department.

ENG

7.5 TROUBLESHOOTING

Contact the Customer Support department in the following cases:

- The device does not operate.

- The product does not maintain its position.

- The light flashes.

- The light beam does not focus.

8. RECYCLING

After the useful life of the unit has come to an end, the device must be taken out of service
and properly cleaned and disinfected for subsequent recycling. For its correct disposal, please
contact an authorized recycling company.

NOTE: Do not dispose of the product with the usual domestic waste.

Take all the disinfection and/or sterilization measures before disposing of the device
so as to not contaminate the environment.

16

9. TECHNICAL DATA

ENG

PHOTOMETRIC AND

ELECTRICAL DATA

Light Source LED 3W

Number of LEDs

Illumination at 30 cm 1.000 Lux (White) N/A 1.000 Lux

Wavelength UVA 365 nanometers 360 nanometers NA (White)

Lenses 3 diopter

IP 20 0

Color temperature 4.500ºK (White) N/A 4.000ºK

Color rendering >80% N/A >80%

Useful life 20.000h (UV) / 50.000h (White) 3.000h 13.000h

Protection Class Class II

Voltage 100/240 V 220/240 V

Frequency 50/60 Hz

Types of plugs available A, B, F, G, I F, G, I

* Optional: FL UV Compact 9W (REF: PHISE9/BLB), same photometric and electrical data as VISTA UV HANDLE H.F.

VISTA LED

HANDLE

4 (2UV + 2White) 4 (2UV + 2White)

VISTA LED PLUS

VISTA UV

HANDLE H.F

FL UV Compact 9WFL Compact 9W

VISTA PLUS H.F

840 *

N/A

ENVIRONMENTAL CONDITIONS FOR OPERATION

Ambient temperature 10 °C a 40 °C

Relative Humidity (without condensation) 30% a 75%

Atmospheric Pressure 700hPa a 1060hPa

ENVIRONMENTAL CONDITIONS FOR STORAGE AND TRANSPORTATION

Ambient temperature -25 °C a 70 °C

Relative Humidity (without condensation) 10% a 75%

Atmospheric Pressure 500hPa a 1060hPa

PHYSICAL

CHARACTERISTICS

Box Dimensions 240x 365x 60 mm 250x 865x 80 mm 240x365x60 mm 250x865x80 mm

Gross Weight 1,26 kg 2,72 kg 1,10 kg 2,64kg

Lighting unit Net Weight 1,06 kg 2,06 kg 0,92 kg 1,98kg

Articulated Arm Length N/A

Grip Dimensions

Head Dimensions 220 x 205 x 45 mm

Magnification Lens Dimensions

Color White

VISTA LED

HANDLE

Ø30mm x 120mm

VISTA LED

PLUS

900mm

(450 + 450)

N/A

100 x 60 mm

VISTA UV

HANDLE H.F

N/A

Ø30mm x 120mm

* continued on next page

VISTA PLUS

H.F

900mm

(450 + 450)

N/A

17

ENG

PHYSICAL

CHARACTERISTICS

LEDs Protector YES N/A

Light Bulb Protector N/A NO

Aluminum Reflector N/A YES

Lens Protection Lid YES YES

Head Rotation N/A 200˚ N/A 200˚

* VISTA LED PLUS and VISTA PLUS H.F. include the AH TABLE CLAMP mounting accessory by default.
* The gross weight of the lighting unit includes the net weight of the AH TABLE CLAMP accessory except the

HANDLE models.

VISTA LED

HANDLE

VISTA LED

PLUS

VISTA UV

HANDLE H.F

VISTA PLUS

H.F

REF MODEL GROSS WEIGHT NET WEIGHT BOX DIMENSIONS

B0101800 WALL B SUPPORT 0,25 KG 0,20 KG 91 x 221 x 122 mm

B010190 AH TABLE CLAMP 0,37 KG 0,29 KG 91 x 221 x 122 mm

82026 RAIL PLUS BRACKET 0,24 KG 0,19 KG 115 x 175 x 75 mm

09651 TROLLEY STAND 8,8 kg 9,18 KG 8,56 KG 160 x 160 x780 mm

B0101S0 EXTENSION ARM 0,74 KG 0,56 KG 160 x 520 x 90 mm

10. ELECTROMAGNETIC EMISSIONS

All electronic devices for medical use must comply with the requirements of the IEC 60601-1-2
standard.

Likewise, it is mandatory to respect the precautions, the information in the Electromagnetic
Compatibility (EMC) guide included in this manual and the verification of all medical devices in
simultaneous operation to ensure the electromagnetic compatibility and the coexistence of all
other medical devices before undertaking a surgical procedure.

MANUFACTURER DIRECTIVES AND DECLARATION – ELECTROMAGNETIC EMISSIONS

Our devices are designed to be used in an ELECTROMAGNETIC ENVIRONMENT as specified below. The user must
ensure that the units can operate in that environment.

NOTA: Home health care settings have higher immunity requirements than professional medical care facilities. Therefore,
the interference immunity requirements for professional medical care centers are included here.

EMISSIONS TESTS

STANDARD BASIC EMC

Conducted RF Emissions
CISPR11

Radiated RF Emissions
CISPR11

Harmonic Distortion
IEC (EN) 61000-3-2

Voltage Fluctuations and Flashing
IEC (EN) 61000-3-3

COMPLIANCE ELECTROMAGNETIC ENVIRONMENT

Group 1

Class B

Class A

The device only uses RF energy for its internal operations. Its
RF emissions are therefore very low and are unlikely to cause
interferences with nearby electronic equipment.

The device is suitable to be used in all establishments, including
domestic establishments and those connected directly to the
public low-voltage power mains that supply buildings used for
domestic purposes.

18

MANUFACTURER DIRECTIVES AND DECLARATION – ELECTROMAGNETIC IMMUNITIES

Our devices are designed to be used in an ELECTROMAGNETIC ENVIRONMENT as specified below. The user must
ensure that the units can operate in that environment.

NOTE: Home health care settings have higher immunity requirements than professional medical care facilities. Therefore,
the interference immunity requirements for professional medical care centers are included here.

STANDARD BASIC EMC

IMMUNITIES TEST

Electrostatic Discharge (ESD)
IEC (EN) 61000-4-2

Electrical Fast Transients
(bursts)

IEC (EN) 61000-4-4

Mains surge
IEC (EN) 61000-4-5

Voltage Drops
IEC (EN) 61000-4-11

Magnetic Field at Industrial
Frequency

IEC (EN) 61000-4-8

Radiated Radiofrequency

IEC (EN) 61000-4-3

Conducted Radiofrequency

IEC (EN) 61000-4-6

TEST LEVEL

IEC 60601

±8kV

Contact

±15kV

Air

±2kV for power lines

±1kV between

phases

±2kV between

phases and earth

±1kV for input/

output/earth lines

0% UT (100% drop

in UT); 0.5 cycles

40% UT (60% drop

in UT); 10 cycles

0% UT (100% drop

in UT); 5s

30 A/m 30 A/m

10 V/m

80MHz - 6GHz

10V

150kHz - 100MHz

COMPLIANCE ELECTROMAGNETIC ENVIRONMENT

±8kV

Contact

±15kV

Air

±2kV for power lines

±1kV between

phases

±2kV between

phases and earth

±1kV for input/

output/earth lines

0% UT (100% drop

in UT); 0.5 cycles

40% UT (60% drop

in UT); 10 cycles

0% UT (100% drop

in UT); 5s

10 V/m

80MHz - 6GHz

10V

150kHz - 100MHz

Floors must be made from wood,
concrete or ceramic tiles.

If the floors are covered in synthetic
material, the relative humidity must be at
least 30%.

The quality of the electrical supply
network must be equivalent to that of a
commercial or hospital setting.

The quality of the electrical supply
network must be equivalent to that of a
commercial or hospital setting.

The quality of the electrical supply
network must be equivalent to that
of a commercial or hospital setting.
If the device user requires continued
use during power cuts, we recommend
powering the device with a different
power source or battery.

Magnetic fields at industrial frequency
must be those of a typical hospital or
commercial setting.

The distance between portable or
mobile radiofrequency communication
equipment and the device, including
cables, must not be less than the
recommended separation distance,
which is calculated using the applicable
equation for the transmitter frequency.

Recommended separation distance:

d = 1,2√P; < 80MHz
d = 1,2√P ; de 80MHz - 800MHz
d = 2,3√P ; de 800MHz - 2,7GHz

P is the maximum rated power output

of the transmitter in watts (W) and d is
the recommended separation distance in
meters (m).

ENG

NOTE 1: UT is the AC network voltage before applying the test level.
NOTE 2: The upper frequency range is applied at 80MHz and 800MHz.
NOTE 3: These directives may not be applicable in all situations. Electromagnetic propagation is affected by the absorption

and reflection of structures, objects and people.

19

11. WARRANTY

The Buyer must report any visible damage to the Products within a maximum of forty-eight
(48) hours of receipt. After this time, MIMSAL will not be liable for the apparent damages the
products may have and that have not been reported by Buyer.

MIMSAL offers a guarantee of five (5) years from delivery on any defects that the Products may
have.

It will be understood that the Products have a defect when, without having suffered any damage
after their delivery, they are not suitable for use or they have a quality or performance level that
is inferior to that stated in their technical specifications. It will be up to the Buyer to prove that
the Product is non-compliant.

To exercise the warranty, the Buyer must inform MIMSAL in writing by sending an email to
[e-mail], indicating the defect, identifying the Product, the Batch number, the REF
number of the purchase order and a photograph of the Product. This email must be sent within
a maximum of ten (10) days of detecting the Product defect.

Upon receipt of this email, MIMSAL will try to see if it is possible to resolve the incident remotely,
in which case it will respond to the Buyer with instructions on how to proceed or, conversely, if
the Product must be sent to MIMSAL to be examined and, if necessary, repaired or replaced.
The shipment of Products (including disassembly, transport, taxes, etc.) will be at the expense
of the Buyer.

The warranty will consist of the repair or replacement of the Products, its elements and/or
installation that are defective or deficient, or a refund for the amount of the price at MIMSAL’s
discretion.

The warranty granted to the Buyer by MIMSAL will not be applicable in the following cases:

- When the Products have not been used, stored, conserved, installed, handled, etc. in
accordance with the instructions given by MIMSAL.

- When the Products have been manipulated, altered or modified by third parties.

- When the origin of the defects is not due to issues related to their manufacture or defects
in the quality of their components.

- In the case of damage and/or defects suffered due to wear and tear from normal use of the
Products.

The defective Products and/or materials that have been replaced by others will remain the
property of MIMSAL. The warranty established in this clause is exclusive and replaces all
other warranties related to the Products.

ENG

20

12. INDUSTRIAL AND INTELLECTUAL PROPERTY

All of the industrial and intellectual property rights relating to the Products, as well as the
designs, texts, labeling, images, graphics, brands, technical documentation, manuals, etc., are
the exclusive property of MIMSAL and the Buyer acknowledges and accepts this. In any case,
these rights are protected by the regulations governing intellectual and industrial property,
meaning it is forbidden to reproduce, modify, distribute and/or manipulate them.

Also, the Buyer will collaborate with MIMSAL in the maintenance of said intellectual and
industrial property rights, immediately notifying MIMSAL of any action or circumstance that
may infringe them and refraining from carrying out such actions.

The Buyer is obliged to abstain from registering in their name or in the name of third parties,
brands or trademarks that are identical or similar to those used by MIMSAL or that could cause
confusion for customers regarding the identity or character of MIMSAL or of the Products.

It is expressly forbidden to use the Products or any element of Industrial or Intellectual Property
related to the Products that are the property of MIMSAL in such a way that may constitute
a violation of the rights protected by law and specifically by any applicable legislation on
Industrial and Intellectual Property.

MIMSAL reserves all actions that may protect it in the defense of its interests and rights.

13. CONFIDENTIALITY

All of the industrial and intellectual property rights relating to the Products, as well as the
designs, texts, labeling, images, graphics, brands, technical documentation, manuals, etc., are
the exclusive property of MIMSAL and the Buyer acknowledges and accepts this. In any case,
these rights are protected by the regulations governing intellectual and industrial property,
meaning it is forbidden to reproduce, modify, distribute and/or manipulate them.

ENG

21

14. DECLARATION OF CONFORMITY

DECLARACIÓN UE DE CONFORMIDAD

EU DECLARATION OF CONFORMITY

ENG

nº 2108

FABRICANTE PRODUCTO

PRODUCT MANUFACTER

Dirección

Address

MIMSAL TRADE S.L.

C. Mollet 17, Polígono Industrial Palou Nord
08401 Granollers (Barcelona)
Spain

DECLARAN BAJO SU RESPONSABILIDAD QUE EL PRODUCTO

DECLARE UNDER THEIR RESPONSIBILITY THAT THE PRODUCT

Nombre del producto - BASIC UDI-DI

Product name - BASIC UDI-DI

Tipo

Type

Referencia - Modelo - UDI-DI

Reference - Model - UDI-DI

Finalidad prevista

Intended purpose

CUMPLE LOS REQUISITOS DEL REGLAMENTO (UE) 2017/745 SOBRE PRODUCTOS SANITARIOS

COMPLIES WITH THE REQUIREMENTS OF REGULATION (EU) 2017/745 ON MEDICAL DEVICES

Lente convexa de aumento que concentra la luz eléctrica procedente de una
fuente integrada, sobre los objetos visualizados

A convex lens with a built-in electrical light source intended to be used to concentrate
light upon and magnify an object(s) being viewed

Clasificación producto sanitario

Medical device classification

Ensayos y medidas - Normas

Test and measurements - Standards

UNE-EN 60601-1:2008+/A12:2015 Part 1 Medical equipments
UNE-EN 60601-1-2:2015 Part 2 Medical equipments
UNE-EN 60601-2-41:2010+A11:2012+A1:2015

VISTA 843656286VISTAS4

LUMINARIA CON LENTE DE AUMENTO

MAGNIFIER LAMP

E051L - VISTA LED HANDLE - 8436562860462
E051PL - VISTA LED PLUS - 8436562860479

CLASE I - REGLA I

Class I - Rule I

Accesorios

Accessories

Lugar y fecha

Location and date

Nombre y cargo

Name and position

B0101800 - WALL B SUPPORT
B010190 - AH TABLE CLAMP
82026 - RAIL PLUS BRACKET

Granollers (Barcelona) España, a 11 de FEBRERO de 2022

Granollers (Barcelona) Spain, February 11th, 2022

Xavier Codina Jané

Director General

General Manager

09651 - TROLLEY STAND 8,8 kg
B0101S0 - EXTENSION ARM

Oriol Codina Miró

Responsable Técnico

Technical Manager

22

DECLARACIÓN UE DE CONFORMIDAD

EU DECLARATION OF CONFORMITY

ENG

nº 2109

FABRICANTE PRODUCTO

PRODUCT MANUFACTER

Dirección

Address

MIMSAL TRADE S.L.

C. Mollet 17, Polígono Industrial Palou Nord
08401 Granollers (Barcelona)
Spain

DECLARAN BAJO SU RESPONSABILIDAD QUE EL PRODUCTO

DECLARE UNDER THEIR RESPONSIBILITY THAT THE PRODUCT

Nombre del producto - BASIC UDI-DI

Product name - BASIC UDI-DI

Tipo

Type

Referencia - Modelo - UDI-DI

Reference - Model - UDI-DI

Finalidad prevista

Intended purpose

CUMPLE LOS REQUISITOS DEL REGLAMENTO (UE) 2017/745 SOBRE PRODUCTOS SANITARIOS

COMPLIES WITH THE REQUIREMENTS OF REGULATION (EU) 2017/745 ON MEDICAL DEVICES

Lente convexa de aumento que concentra la luz eléctrica procedente de una
fuente integrada, sobre los objetos visualizados

A convex lens with a built-in electrical light source intended to be used to concentrate
light upon and magnify an object(s) being viewed

Clasificación producto sanitario

Medical device classification

Ensayos y medidas - Normas

Test and measurements - Standards

VISTA 843656286VISTAS4

LUMINARIA CON LENTE DE AUMENTO

MAGNIFIER LAMP

E051CAO012 - VISTA PLUS H.F - 8436562860028
E051LAT212 - VISTA UV HANDLE H.F - 8436562860035

CLASE I - REGLA I

Class I - Rule I

UNE-EN 60601-1:2008+/A12:2015 Part 1 Medical equipments
UNE-EN 60601-1-2:2015 Part 2 Medical equipments
UNE-EN 60601-2-41:2010+A11:2012+A1:2015

Accesorios

Accessories

Lugar y fecha

Location and date

Nombre y cargo

Name and position

B0101800 - WALL B SUPPORT
B010190 - AH TABLE CLAMP
82026 - RAIL PLUS BRACKET

Granollers (Barcelona) España, a 11 de FEBRERO de 2022

Granollers (Barcelona) Spain, February 11th, 2022

Xavier Codina Jané

Director General

General Manager

09651 - TROLLEY STAND 8,8 kg
B0101S0 - EXTENSION ARM

Oriol Codina Miró

Responsable Técnico

Technical Manager

23

This is to certify that the manag ement system of

has been found to conform to the Quality Management System standard:

15. CERTIFICATE ISO 9001

MANAGEMENT SYSTEM
CERTIFICATE

ENG

Certificate no.:
283445-2019-AQ- IBE-ENAC

Initial certification date:
20 April 2016

Valid:
21 April 2022 – 20 April 2025

MIMSAL TRADE, S.L.

Calla Mollet 17, Pol. Ind Palou Nord, 08401, Granollers, Barcelona, Spain

ISO 9001:2015

This certificate is valid for the following scope:

Manufacturing and distribution of medical devices for the lighting market.

Place and date:

Barcelona, 28 February 2022

For the issuing office:

DNV -

Business Assurance
Gran Via de les Corts Catalanes 130
08038, Barcelona, Spain

-136, Pl. 9,

Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.

ACCREDITED UNIT: DNV GL Business Assurance España, S.L.U., Gran Via de les Corts Catalanes 130-136, Pl. 9, 08038 Barcelona, Spain
www.dnv.es/assurance

Ana del Rio Salgado

Management Representative

-

TEL: [phone]

.

24

This is to certify that the management system of

has been found to conform to the Quality Management System standard:

16. CERTIFICATE ISO 13485

MANAGEMENT SYSTEM
CERTIFICATE

ENG

Certificate no.:
283446-2019-AQ-IBE-ACCREDIA

Initial certification date:
27 December 2017

Valid:
09 February 2022

–08 February 2025

MIMSAL TRADE, S.L.

Calla Mollet 17, Pol. Ind Palou Nord, 08401, Granollers, Barcelona, Spain

ISO 13485:2016

This certificate is valid for the following scope:

Design, management of production and placing on the market of medical devices (lamps)
for the lighting healthcare market.

Place and date:

Vimercate (MB), 02 February 2022

For the issuing office:

DNV -

Business Assurance
Via Energy Park, 14,
Italy

-

20871 Vimercate (MB)

-

Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.

ACCREDITED UNIT: DNV Business Assurance Italy S.r.l., Via Energy Park, 14 - 20871 Vimercate (MB)

Claudia Baroncini

Management Representative

- Italy -

TEL: [phone]. www.dnv.i t

25

ENG

MIMSAL TRADE S.L.

C/ Mollet, 17

Polígono Industrial Palou Nord

08401 – Granollers (Barcelona) SPAIN

Tel. [phone]

mimsal@mimsal com

www.mimsal.com

F3P29

Rev. 01

20.06.2022