Triango 100 C Small Surgical Lamp Instruction Manual

Triango 100 C Small Surgical Lamp

Specifications:

• Product Name: Triango Lamp 100
• Type: Treatment Lamp (Small Surgical Lamp)
• Intended Use: Operating rooms for diagnosis or treatment support
• Operation: Continuous
• Not Intended for: Combination with other medical devices

Product Usage Instructions

Safety Instructions:
Ensure that the lamp is used only by individuals with the appropriate training and qualifications as mentioned in the user manual.

Mounting:
Follow the mounting instructions specific to your version of the lamp (C, W, or F) as outlined in the manual on pages 26-30.

Luminaire Head Assembly:
Assemble the luminaire head according to the instructions provided on page 32.

Operation:
Operate the lamp as needed for diagnosis or treatment support in operating rooms.

Cleaning:
Refer to the cleaning instructions on page 33 to maintain the lamp in good condition.

Safety Inspections:
Regularly perform safety inspections as outlined on page 34 to ensure safe operation.

Demounting:
If demounting is required, follow the instructions provided on page 34.

Additional Information:
For any additional information, refer to page 35 of the manual.

Troubleshooting:
If you encounter any issues, consult the troubleshooting section on page 35 for guidance.

Technical Data:
Refer to page 35 for technical specifications and data related to the Triango Lamp 100.

FAQ:

Q: Can the Triango Lamp 100 be used in combination with other medical devices?
A: No, the lamp is not intended to be combined with other medical devices.

Q: Who should operate the lamp according to the safety instructions?
A: The lamp should be operated only by individuals with the specified training and qualifications mentioned in the manual.

SAFETY INSTRUCTIONS

Intended use

The Triango lamp 100 is a treatment lamp (small surgical lamp). It is an individual lamp for use in operating rooms that is used near the patient to support diagnosis or treatment, which poses no risk to the patient in the event of any interruption caused by light failure. It is meant for continuous operation and is not intended to be combined with other medical devices.

User profiles

• Health Professional
  All individuals who have completed medical training and work in the professional field they trained for.

• Cleaning Specialist
  Trained in national and workplace-connected hygiene regulations.

• Qualified Electrician
  Trained in the areas of electronics and electrical engineering and knows the relevant standards and regulations. Qualified Specialist Qualified due to his technical training, knowledge and experience and knowledge of the rules, to carry out the assembly/demounting.

Safety instructions

Operation by Health Professional

• The instructions form part of the product and must be stored and made available to all future users.
• All work on the luminaire (incl. repairs) may only be performed by a qualified electrician. The assembly may only be performed by a qualified specialist.
• The luminaire may not be altered or manipulated. Only approved genuine parts may be used. Any use other than the one intended with the genuine parts can lead to other technical values and life-threatening hazards.
• Operation in potentially explosive areas is prohibited. The current supply of the luminaire represents a po-tential ignition source.
• The luminaire may only be operated in dry and dust-free rooms.
• The luminaire should not be on without supervision.
• In the case of luminaires with protection class I, the protective earth conductor (PE) must be connected to luminaires housing.
• Do not use a damaged luminaire. Defective cords and a defective ergonomic handle also represent a potential hazard. Do not place a cord near heat sources or sharp edges.
• This product may emit dangerous radiation. Damage to the eyes: never look directly into the light cone.
• Replace damaged lenses before operating the lumi-naire again.
• Only connect the luminaire to the supply network with a protective earth conductor (PE), to prevent an elec-trical shock.
• Do not place extra loads on the luminaire head and the arm system.
• The luminaire must not be covered with a cloth or similar during operation.
• The ventilation openings (if available) must always be kept free during operation!
• The luminaire must not be operated near to external heat sources that exceed the maximum ambient temperature of the luminaire.
• The luminaire must not be used outside the specified ambient conditions.
• The luminaire may only be used for the intended use described here.
• The manufacturer cannot be held responsible for any damages resulting from use deviating from its intended use, or the failure to observe the safety instructions and warnings.
• The Triango 100 F must be secured while being transported within the clinic
• Do not use with medical devices that may react sensitively to a light spectrum within the visible range (such as pulsating light and/or light with a high illumination intensity).
• When using a number of luminaires at the same time, the total irradiance must not exceed Ee 1000W/m2.
• Before connecting to the mains power supply, one must check for matching of network data with device data.

Warning levels

DANGER

• Warning of hazards that can result in death or serious injury if there is a failure to follow the instructions.
• Warning of hazards that can result in injury if there is a failure to follow the instructions.

CAUTION

• Warning of hazards that can result in material damage if  there is a failure to follow the instructions.

Specific fastening instructions

Triango 100 C

• Fastening material is not included with delivery.
• The ceiling mounting must only be mounted on ceilings having a concrete stability class B25 (C20/25) or higher.
• Solid ceiling reinforcement parts must not come into con-tact with the ceiling mounting. If there is any doubt, an au-thorized professional must confirm that mounting is possi-ble on the mounting base being used.
• Borings must be made by specialists in compliance with the boring tolerances for the reinforcement anchor that have been approved by the manufacturer.
• Screws must be tightened carefully using a torque wrench that complies with the instructions of the mounting element manufacturer.

Triango 100 W

• Fastening material is not included with delivery.
  The luminaire must only be mounted on walls that can guarantee a secure hold. Specialist staff will find details of the requirements in (Load data).

VERSIONS

SCOPE OF DELIVERY

TRIANGO 100 C

included with delivery:

TRIANGO 100 W

included with delivery:

Triango 100 F

Included with delivery:

MOUNTING

Triango 100 C

Workload data

Attach ceiling bracket

DANGER

• Assembly by qualified personnel

  • Mounting must be done by qualified personnel only. Lack of appropriate knowledge could be life-threatening.

• Life-threatening danger from a falling luminaire.

  • The ceiling must be made of solid concrete to guarantee a secure hold.
  • Use a suitable fastening.

• Electric shocks are life-threatening.

  • All poles of the luminaire must be separated by an external lockable switch from the power supply network.

• Saw the ceiling conduit to the desired length at the top end using a metal saw and deburr.

• Remove fastening screw 3 .

• Insert ceiling tube 1 into the ceiling bracket 2 and drill with d= 9mm. Use the existing hole in the ceiling bracket. Bore the opposite hole separately.

• Note: pull through the cable after sawing and drilling from the lower side to the upper pipe side (the 3-pin plug first)

• Make 4 bore hole markings (10mm dia.); note the position of opening A for the electrical connection

• Drill holes and blow out with a bellows

• Check the distances between them

• Hold the ceiling bracket on the ceiling and hammer in the fastening anchor using a hammer

• Tighten the fastening using manufacturer instructions

WARNING
Risk of injury from falling parts.

• The ceiling bearing must be secured to the fastening material, that must be suitable for the corresponding ceiling condition.
• Mounting must be performed by two people

CAUTION
Use protective equipment in line with tool manufacturer’s instructions.

• Connect the plug from the ceiling tube with plug on the ceiling arm
• Carefully push protruding cable into the ceiling tube

Perform this assembly step on an even surface:

• Insert the sliding piece 1 above into the ceiling arm groove 2
• Push the ceiling tube 3 and ceiling arm 2 to-gether
• Secure the sliding piece 1 by screwing in the threaded stud 4 (up to the stop)
• Loosen the threaded stud 4 again by a maxi-mum of a ¼ turn and checking the rotating function.
• Place the end ring and ceiling cover on the ceiling tube.
• Pull the ceiling tube cable through the opening A of the ceiling holder
• Insert ceiling tube into the ceiling holder
• Secure the safety screw 1 and the M8 nut
• Tighten the safety screw 1 and the M8 nut (20 Nm)
• Tighten all 4 grub screw 2 (5 Nm)

DANGER
Electric shocks are life-threatening.

• Switch off the fuses before working on the power connection
• This device may only be connected to a mains power supply with a protective earth conductor (PE) to prevent any risk of an electric shock
• Create the power connection
• Connect the ceiling tube plug with the power supply plug
• Push cover and retaining ring over the ceiling bearing and tighten them (0.5Nm)
• Continue with luminaire head assembly.

Triango 100 W

Workload data

Attach ceiling bracket

DANGER

• Assembly by qualified personnel
  Mounting must be done by qualified personnel only. Lack of appropriate knowledge could be life-threatening.

• Danger to life through electric shock

  • All poles of the luminaire must be separated by an external lockable switch from the power supply network.

CAUTION
Determine the fastening means to use accord-ing to the workload data table

• Observe the dimensioning of the rod before assembly

Observe the position of the wall bracket

• Alignment of the wall bracket must be under-taken according to the axis in the picture
• Failure to comply with correct alignment will compromise mechanical safety
• We recommend using a counter-plate on lightweight construction walls (not included with delivery).
• Make 4 bore hole markings (10mm dia. min.); consider the position of opening A for the elec-trical connection
• Check the distances between them
• Drill holes and blow out with a bellows
• Hold the ceiling bracket on the ceiling and hammer in the 4 fastening anchors using a hammer
• Tighten the fastening using manufacturer instructions

DANGER
Electric shocks are life-threatening.

• Switch off the fuse before working on the power connection
• This device may only be connected to a mains power supply with a protective earth conductor (PE) to prevent any risk of an elec-tric shock
• Create the power connection
• Place wall angle 1 (with end ring 2 and hood 3 in position) in the wall bracket 4 and simultane-ously pull plug through the rectangular cutout
• Wall angle in vertical alignment, mount with M8 self-locking 1 bolt and nut and tighten slightly

Mounting the arm for wall-mounting assemble

WARNING
The opening spring balanced arm is an injury hazard

• Do not remove the transport safeguard until after the luminaire head has been mounted.

• Insert the arm for wall-mounting 3 into wall bracket 1 slightly

• Insert the sliding piece 2 into the groove

• Push up the arm 3 in such a way that the hole in the wall bracket is aligned with the hole in the sliding piece

• Screw grub screw 4 into wall bracket

• In the case of a dead stop, screw this back by a ¼ turn and check the turning function

• Continue with luminaire head assembly.

Triango 100 F

• Remove the 4 crosstip screws and remove the power supply pan
• Loosen the 2 Allen screws on the lower support tube
• Feed the support tube cable through the roll tripod
• Fasten the support tube to the roll tripod using 2 Allen screws and serrated washers (10 Nm)
• The cable holder must be aligned at the rear

WARNING
Never unscrew the upper cable holder – risk of injury.

• If both cable holders are unscrewed, the connecting piece will come loose and falls down, which can lead to personal injury and damage to the cable and device.

• Continue with luminaire head assembly.

LUMINAIRE HEAD ASSEMBLY

WARNING
Risk of injury from a falling luminaire head

• Ensure that the luminaire head is secured in an orderly fashion.

• Damage to due to a poorly mounted luminaire head.

• Push together the luminaire head 1 and arm 3; in doing so the cardan joint bracket must be on the left 2 of the luminaire head

• then screw in both countersunk screws M4 (both with a toothed washer) in (1. 5Nm)

• Check the turning function

OPERATION WARNING

Warning against damage to eyes

• Never look directly into the light cone.

Operating function (dependent on the model)

• Switch the luminaire on or off using the button 1.
• The luminaire can be dimmed using the +/- buttons 2
• The light color can be adjusted at 3
• The focus can be adjusted at 4
• The mode of use of the endoscope can be adjusted at 5
• Before each use, perform a function test: all LEDs in the light cone must come on.

Triango 100 F

DANGER
Electric shocks are life-threatening.

• Do not plug in any damaged power cables.
• If there are any signs of damage to the power cable, immediately replace it with a new one.
• Connection voltage and frequency must match data on the type plate.
• Only connect the luminaire to the supply network with a protective earth conductor (PE).

CAUTION
Triango 100 F

• Wind the power cable onto the cable holder when not in operation

• Plug in cable

• Connect cable to the network

CLEANING DANGER

Danger to life through electric shock

• Before cleaning: disconnect the power connection from the network

CAUTION
Material damage due to incorrect cleaning

• For cleaning, only use agents which do not affect functioning of the luminaire.
• For cleaning, do not use any solvent or chlorine based or abrasive detergents as they can, among other things, result in cracking of plastic parts.
• The cleaning agents used must be ap-proved for use on plastics such as PC, PMMA, PA and ABS.
• Damage to the luminaire due to concen-trated disinfectant.
• For concentration and application times, please consult the information provided with the agent used.
• Use of the wrong cloths can make scratches

CAUTION
Dirt reduces the luminosity

• Keep cover clear through regular cleaning.
• Only wipe cleaning allowed.

Recommended cleaning agent
Use a mild soap solution or commercially available detergent as a cleaning agent. Wipe the surfaces of the devices with a slightly moistened cloth; add a mild soap solution (detergent) if necessary. Finally wipe dry the outer surfaces using a soft, clean cloth.

CAUTION
Clean external luminaire parts using the following prescribed diluted products:

• Lysoformin®
• Dismozon®
• Hexaquart®plus
• Sagrotan® quick disinfectant cleaner

CAUTION
To minimize the risk of disease transmission, in addition to complying with this user manual, you must also comply with the applicable occupational health and safety regulations and the requirements of national bodies with responsibilities for hygiene and disinfection.

Sterilization of the ergonomic handle

• Sterilization must be carried out in accordance with ISO 17665-1 (Sterilization of health care products in moist heat). CAUTION

Damage to the hand grip

• Do not sterilize with hot air
• Package the hand grip in a sterile bag before sterilization.
• The hand grip is designed exclusively for damp sterilization with 3 times fractioned pre-vacuum and saturated steam with the follow-ing parameters:

WARNING
Warning against burns

• The ergonomic handle must be cooled to room temperature before use.
• After sterilization check the ergonomic handle for mechanical integrity; do not continue to use damaged ergonomic handles

SAFETY INSPECTIONS

DANGER
Electric shocks are life-threatening.
Deenergize the device/pull out the mains plug and secure against being switched on again.

CAUTION

• Maintenance and repairs can only be performed by qualified electricians.
• The corresponding user profile is in Section 2

Safety instructions. annually:

• Check the power supply cable for damage and replace if necessary
• Check the fastening screw on the underside tripod foot and tighten if necessary.
• Paint damage
• Cracks on plastic parts
• Deformation of the carrier system
• Loosening of parts

Setting the spring force

CAUTION
The spring force is set at the optimum setting in the factory.

• As a first measure slightly tighten the joint cover (by a ¼ turn); this to achieve greater stability of the luminaire head, if necessary Otherwise:
• Remove the service cover of the spring balanced arm (loosen the 2 crosstip screws)
• Place a suitable tool (e.g. a 3-type Allen key) into the hole 1 , turn by ¼ turn in the direction of the arrow, a repeat a number of times until the desired stability is reached
• Screw the service cover on again (attention: do not tighten too strongly)

DEMOUNTING

DANGER

• Electric shocks are life-threatening.
  • Disconnect the power connection from the network
• Risk of injury
  • The spring balanced arm is under a high spring force. If the terminal device is not in the uppermost spring balanced arm position,the spring balanced arm will move rapidly upwards and lead to severe injuries.
    Only disassemble the terminal device when the spring balanced arm is in the uppermost position

Disposal
Do not place the luminaire in the household waste. Bring the luminaire and lamp, according to local regulations, to a disposal site or give it to a dealer with the appropriate service offering.
Cut the cable directly at the casing.

The products listed above are over 95% recyclable. In order for a high percentage of the used materials to either be physically re-used or used for energy after the end of this product’s life cycle, the luminaires have been designed with recycling in mind. Theydo not contain hazardous or supervision- requiring substances.

ACCESSORIES

ADDITIONAL INFORMATION
Additional documents may be requested from the manufacturer for this product.
Using this luminaire does not present a risk to other equipment.
To save energy, the luminaire should only be switched on when it is actually needed.
The expected service life of the luminaire is 10 years.
The radiation emitted by this product represents the exposure limit value for reduction of the risk of pho-tobiological dangers on the basis of IEC 62471.

TROUBLESHOOTING

TECHNICAL DATA

Electrical Data:|
---|---
Rated input voltage| 100 – 240 VAC
Frequency range| 50 / 60 Hz
Power consumption| 65 – 80 VA
Input current| 320 – 640 mA
Power factor| 0.41-0.52
Integral electronic transformer| 24 VDC output
Photometric values:|
---|---
Central illuminance Ec at 1.0m distance| 100‘000 lx *
Light field diameter d10 at a distance of 1.0 m: Triango 100-1, Triango 100-3, Triango Endo 100-1

Triango Fokus 100-1, Triango Fokus 100-3

| ****

dia. = 18 cm *

dia. = 18 cm / 23 cm / 28 cm*

Light field diameter d50 at a distance of 1.0 m:| dia. = 10.9cm *
Color temperature:

Triango 100-1, Triango Fokus 100-1, Triango Endo 100-1

Triango 100-3, Triango Fokus 100-3

| ****

4300K *

3700K/ 4300K/ 4700K*

Color rendering Index Ra| 95*
Color rendering Index R9:

Triango 100-1, Triango Fokus 100-1, Triango Endo 100-1

Triango 100-3, Triango Fokus 100-3

| ****

90*

95*

Depth of illumination L1 + L2| 100 + 20.5 cm
 | * -10% / +20% tolerance
Ambient conditions for transport, storage and operation:|
---|---
Ambient temperature (storage and transport)| -20°C to +70°C
Ambient temperature (operation)| 10°C to +35°C
rel. air humidity (non-condensing)| max. 75%
Weight:|
---|---
Luminaire head| 2.4 kg
Triango 100 C| 15.9 kg
Triango 50 Wall| 15.3 kg
Triango 100 F| 20.0 kg
Operating mode:|
---|---
Operating mode| Continuous operation
Classification:|
---|---
Triango 100| Protection class I
Degree of protection according to IEC 60529 Luminaire head| IP 20

IP 43 (horizontal position)

Classification according to 93/42 ECC – Annex IX (Medical Device Class)

U.S. FDA Device Class

| Class I Class I
Electrical safety testing and EMC according to:| ANSI/AAMI ES60601-1 CAN/CSA-C22.2 No 60601-1

EN/IEC 60601-1

EN/IEC 60601-2-41

EN/IEC 60601-1-2

Blue light danger according to EN/IEC 62471| RG 1 (low risk)
Life cycle of the light source:|
---|---
Life cycle| 50,000 h (L70/B50)

ELECTROMAGNETIC COMPATIBILITY (EMC)

Guidelines – Electromagnetic disturbance emissions

The medical device is intended for operation in an electromagnetic environment such as described below. The user must ensure that it is operated in such an environment.
Emissions| Compliance ac- cording to| Electromagnetic environment
RF emissions (CISPR 11)| Group 1| The medical device uses RF energy only for its internal function. Therefore, its RF emissions are very low and it is unlikely that nearby electronic devices will be affected.
RF emissions (CISPR 11)| Class A| The health care product is designed for use in non-residential homes and

those that are connected directly to a public low voltage distribution systems that also supplies the home.

Harmonic emissions (IEC 61000-3-2)| Class A|
Voltage fluctuations / flicker emissions (IEC 61000-3-3)| Compliant|
Guidelines – Electromagnetic immunity

The medical device is intended for operation in an electromagnetic environment such as described below. The user must ensure that it is operated in such an environment.
Immunity against| IEC 60601-1-2 test level| Conformance level of the medical device| Electromagnetic environment
Electrostatic discharge (ESD) (IEC 61000-4-2)| Contact discharge: ± 8 kV Air discharge: ± 15 kV| ± 8 kV

± 15 kV

| Floors are preferably made of wood, concrete or

ceramic tiles. In the case of synthetic floor covering, the relative humidity should be at least 30%.

Rapid transient electrical disturbances: Bursts (IEC 61000-4-4)| Power cables: ± 2 kV Longer input and

output power cables: ± 1 kV

| ± 2 kV

Not applicable

| The quality of the supply voltage should correspond to that of a typical business or hospital environment

.

Impulse voltage/surges (IEC 61000-4-5)| ±1 kV voltage outer conductor – outer conductor

±2 kV voltage outer conductor – earth

| ±1 kV

n/a

| The quality of the supply voltage should correspond to that of a typical business or hospital environment

.

Magnetic field at the supply frequency

(50/60 Hz)

(IEC 61000-4-8)

| 30 A/m| 30 A/m| Devices with strong line-frequency magnetic fields (transformer stations, etc.) should not be operated in the vicinity of the medical device.
Voltage dips and interruptions in the power supply

(IEC 61000-4-11)

| <5% Vt (>95% dip in Vt) 0.5 cycle

at 0°, 45°, 90°, 135°, 180°, 225°,

270°, and 315°

<5% Vt (>95% dip in Vt) 1 cycle

at 0°

40%Vt (60% dip in Vt) for 5 cycles

|  | The quality of the supply voltage should correspond to that of a business or hospital environment. If the user requires continued functioning during interrup- tions in the power supply, we recommend powering the medical device from an uninterruptible power supply or a battery.
 | 70% Vt(30% dip in Vt) for 25/30 cycles (50 Hz/60 Hz) at 0°|
 | <5% Vt (>95% dip in Vt) dropout|
 | 250/300 cycles|
 | 50 Hz, 60 Hz|
Emitted RF disturbance (IEC 61000-4-3)| 80 MHz up to 2.5 GHz: 10 V/m| 10 V/m| Recommended separation distance from portable and mobile RF devices in transmission power PEIRP of the medical device including its cords: d = 0.35√ P
Conducted RF interference (IEC 61000-4-6)| 150 kHz up to 80 MHz: 3 V| 3 V| Recommended separation distance from portable and mobile RF devices in transmission power PEIRP of the medical device including its cords: 80 MHz – 800 MHz: d = 1.2√P

800 MHz – 2.5 GHz:  d = 2.3√P

d = recommended separation distance [m], P = nominal power of transmitter [W]. The field strength of stationary radio transmitters should be for all frequencies, according to an on-site examination, less than the compliance level. Faults are possible in the area around devices which are marked with the following pictogram:
Recommended safety distances to portable and mobile RF communications equipment

Power of transmitter [W]| 150 kHz – 800 MHz

d = 1.2√p

| 800 MHz – 2.5 GHz

d = 2.3√p

0.01| 0.12 m (0.39 ft)| 0.23 m (0.76 ft)
0.1| 0.38 m (1.25 ft)| 0.73 m (2.4 ft)
1| 1.2 m (3.9 ft)| 2.3 m (7.6 ft)
10| 3.8 m (12.5 ft)| 7.3 m (23.9 ft)
100| 12m (39 ft)| 23 m (76 ft)

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