MIMSAL MS Bedienungsanleitung
ENG
USER MANUAL
MS
EXAMINATION LAMP
MS LED
MS LED PLUS
MS FLEX
MS FLEX PLUS
MS CEILING
MS CEILING PLUS
F3P30
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. +34 930 139 860
mimsal@mimsal com
www.mimsal.com
ENG
3
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
3.6 Ceiling Support 13
4. Operation of the lighting unit 15
4.1 Check before each use 15
4.2 Operation of the lighting unit head 15
4.3 Arm measurement detail by MS model 16
5. Safety functions 18
5.1 Voltage drop 18
5.2 Power cuts 18
5.3 Electrical malfunction 18
6. Cleaning/Disinfection 18
6.1 General safety instructions 18
6.2 Cleaning 18
6.3 Disinfection 19
7. Maintenance 19
7.1 Lighting unit support arms 19
7.2 Lighting unit head 20
7.3 Repairs 20
7.4 Adjustments 20
7.5 Troubleshooting 20
8. Recycling 20
9. Technical data 21
10. Electromagnetic Emissions 22
11. Warranty 24
12. Industrial and Intellectual Property 25
13. Confidentiality 25
14. Declaration of Conformity 26
15. Certificate ISO 9001 27
16. Certificate ISO 13485 28
ENG
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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.
HUMIDITY
Shows the permitted humidity values of between 10% and 75% for transportation and storage.
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.
SAFETY RULES
ENG
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REFERENCE AND MODEL
REF MODEL UDI-DI
M187001C MS CEILING PLUS 8436562860493
M183500C MS CEILING 8436562860486
M187001 MS LED PLUS 8436562860394
M183500 MS LED 8436562860387
M187001FL MS FLEX PLUS 8436562860431
M183500FL MS FLEX 8436562860424
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!
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.
ENG
6
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.
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.
ENG
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SUPPORTS FOR: MS CEILING PLUS | MS CEILING
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
* All of these MS models include the AH TABLE CLAMP mounting accessory by default.
MODEL SUPPORT
CEILING SUPPORT Ceiling bracket
* The MS CEILING PLUS and MS CEILING already include a CEILING SUPPORT.
* Not compatible with MS LED, MS LED PLUS, MS FLEX and MS FLEX PLUS.
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.
SUPPORTS FOR: MS LED PLUS | MS LED | MS FLEX PLUS | MS FLEX
ENG
8
1u. 8,8 Kg
Allen n. 2
3.1 TROLLEY STAND
REF MODEL DESCRIPTION
09651 TROLLEY STAND 8,8 Kg 8.8 Kg rolling base
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
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.
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.
Check regularly that the unit is still stable in order to avoid the possibility of the
lighting unit falling down.
ENG
9
3.2 AH TABLE CLAMP
REF MODEL DESCRIPTION
B010190 AH TABLE CLAMP Table clamp
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).
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.
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.
Check regularly that the unit is still stable in order to avoid the possibility of the
lighting unit falling down.
ENG
10
3.3 WALL B SUPPORT
REF MODEL DESCRIPTION
B0101800 WALL B SUPPORT Reinforced wall B bracket. 7 cm shaft-wall separation.
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).
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.
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.
Check regularly that the unit is still stable in order to avoid the possibility of the
lighting unit falling down.
Andere Handbücher für MS
1
Dieses Handbuch passt für folgende Modelle
12
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