Instructions for Use

NUVO Verde Surgical Lights

Verde NV3
Verde NV4

October 2008
 Verde
Surgical lights

CONTENTS

1. INTRODUCTION ............................................................................................................................. - 3 -
1.1 General information ................................................................................................................... - 3 -
1.2 Information about product liability ............................................................................................. - 3 -
1.3 Receiving inspection ................................................................................................................. - 4 -
1.4 Medical Devices Directive ......................................................................................................... - 4 -
1.5 Type plate .................................................................................................................................. - 4 -
2. COMMISSIONING ........................................................................................................................... - 5 -
2.1 Range of application (purpose) ................................................................................................. - 5 -
2.2 Safety information ..................................................................................................................... - 5 -
2.3 Installation ................................................................................................................................. - 6 -
2.4 Visual and performance check .................................................................................................. - 6 -
2.5 Cleaning, sterilization, disinfection ............................................................................................ - 7 -
3. OPERATION.................................................................................................................................... - 8 -
3.1 Functions of control unit ............................................................................................................ - 8 -
3.2 Adjustment of light field size ...................................................................................................... - 9 -
3.3 Endo mode ................................................................................................................................ - 9 -
3.4 Replacement of the sterilizable handle ..................................................................................... - 9 -
4. MAINTENANCE............................................................................................................................. - 10 -
4.1 Replacement of light sources .................................................................................................. - 10 -
4.2 Mechanical adjustment points ................................................................................................. - 11 -
4.2.1 Overview of adjustment points ......................................................................................... - 11 -
4.2.2 Brake adjustment ............................................................................................................. - 12 -
4.2.3 Adjusting the spring-force of spring arm .......................................................................... - 14 -
4.2.3.1 Adjusting the spring-force of spring arm for standard cardanic................................ - 14 -
4.2.3.2 Adjusting the spring-force of spring arm for flat cardanic ......................................... - 16 -
4.2.4 Adjusting the height restriction of spring arm................................................................... - 17 -
4.3 Spare parts .............................................................................................................................. - 18 -
4.3.1 Sterilizable Handle ........................................................................................................... - 18 -
4.3.2 LED boards ...................................................................................................................... - 18 -
5. DECLARATION OF MANUFACTURER ........................................................................................ - 18 -
6. TECHNICAL DATA ........................................................................................................................ - 19 -
6.1 Lighting data ............................................................................................................................ - 19 -
6.2 Electrical data .......................................................................................................................... - 19 -
6.3 Mechanical data ...................................................................................................................... - 20 -
6.4 Classification ........................................................................................................................... - 20 -
6.5 Interfaces ................................................................................................................................. - 20 -

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 Verde
Surgical lights

1. INTRODUCTION

The Verde NV3 and Verde NV4 Surgical Lights consist of a light head and cardanic counterbalance
arm mounted to a suspension arm system.

The light head is fixed to a cardanic-type support (vertical gimbal joint, horizontal gimbal joint), and can
be rotated, swivelled and tilted in any direction. Height is adjusted via the 360º rotating counterbalance
arm. The position of the light head is adjusted via the 360º rotating suspension arm.

1.1 General Information

These instructions for use are considered as being part of the equipment. They must be kept in the
vicinity of the equipment at all times. Precise observance of the instructions for use is a prerequisite for
proper use and correct operation of the equipment and is essential for the safety of patients and
personnel.

Only NUVO accessories that have been tested together with the device and are listed within the
instructions for use may be used. If accessories are used that are not listed in the instructions for use,
their suitability for use must be tested in accordance with the safety specifications.

The documentation in its entirety relates to the equipment model and current basic safety regulations
at time of going to press. All rights are reserved for equipment, switches, procedures, software
programs and names.

1.2 Information about Product Liability

NUVO Inc. considers itself responsible for the consequences of safety, reliability and performance of
the equipment only if:

a) Installation, modification or repair procedures have been performed only by NUVO Inc. or an agent
expressly authorized for these purposes by NUVO Inc.

b) Electrical installation of the room complies with NEC regulations.

c) The equipment is used in accordance with the instructions for use.

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Surgical lights

1.3 Receiving Inspection

Please inspect the equipment and accessories immediately after receipt for any transportation damage
and defects.

Claims for damage will only be valid if the vendor (NUVO Inc.) or the carrier is informed at once.

A damage report must then be prepared immediately. The damage report must be sent to an agent of
NUVO Inc. near to you or directly to NUVO Inc.

If a light or parts of a light are returned, original packaging materials should be used where possible. If
this packaging material is not available any more, adequate packaging must be used for prevention
damage during transit. The following documentation must be attached:

• Name and address of user,

• Part number and serial number (see type plate),
• Description of deficit.
• RA (Return Authorization) number.

1.4 Medical Devices Directive

The device complies with the demands of the Medical Devices Directive of the European Community
93/42/EC.

1.5 Type plate

The type plate of the light head is found on the rear of the control unit.

NUVO Inc NUVO Inc

Verde NV4 Verde NV3

Serial #: 0001 Serial #: 0002

162 LED 1W 111 LED 1W

28V CE 28V CE

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 Verde
Surgical lights

2. COMMISSIONING

2.1 Range of Application

The NUVO Surgical Light is a medical light for use in therapy rooms or operating rooms in hospital
environments. It is used for local illumination of the patient's body, enabling illnesses, injuries and
afflictions to be recognised and treated. It may only be used within rooms correctly designed according
to the National Electrical Codes.

Fundamentally, an individual light head should not be used for operations where in the case of a light
failure a serious threat of danger to the patient may arise. Light combinations with two or even three
light heads offer a greater safeguard against light failure and additionally supply higher brightness
levels for the surgical operation area.

2.2 Safety Information

• Incorrect use and non-observance of safety specifications may lead to serious injury. You should
read and correctly understand the information documented within the instructions for use for the
NUVO Surgical Lights.

• The light has not been designed for use in areas prone to danger of explosion.

• Never look into the switched-on light from the front, and do not place reflective objects into the path
of the beam. Danger of glare exists due to the high illuminance level.

• The distance between light emission surface of the switched on light and surface of the patient
should not be less than 24 inches (60 cm) in order to guarantee suitable lighting conditions.

• The light must not be operated if the covers are damaged or destroyed.

• Do not place any objects on the lamp housing or hang objects on arms or lamp housings, as this
may compromise the stability of the fixing and there is the danger that these objects may fall into
the surgical area. Attaching or hanging heavy objects can destroy the mechanism.

• The light housing may not be covered up during operation as this will impair heat exchange with the
surroundings and may lead to overheating of the surgical light.

• Collision of supporting arms with light heads must be avoided. A heavy collision may lead to lights
becoming damaged or components breaking off and falling into the surgical area.

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 Verde
Surgical lights

2.3 Installation

Mounting and installation of the NUVO Surgical Light may only be carried out by installation
companies authorised by NUVO Inc.

Installation of lights to the ceiling must be carried out according to the 'Pre-Installation' Instructions for
the Verde Surgical Light.

Incorrect installation may cause damage of the ceiling structure which could lead to the light falling
down. This may cause critical injury to patients and personnel.

Electrical installation on-site must comply with the National Electrical and local codes.

The light is intended solely for use with the following original NUVO Power Supply:
• Verde H/L Powerbox 90-250 VAC or
• Verde L Powerbox 22-31AC 24-44DC
Please consult the installation instructions for further information.

2.4 Visual and Performance Check

Prior to initial operation the operator should check for correct installation and safe operating condition
of the NUVO Surgical Light.

A visual inspection of the following points must take place:

• After switching-on the unit, light must be emitted.

• Inspection of the housing and covers.

If either the housing or one of the covers is damaged or broken, the light must be switched off
immediately and must not be used until the defect is rectified.

• Check the operational state of the control unit.

Individual functions must be checked by activating the appropriate push buttons. The control unit
displays faults in the main circuit of the control electronics of the NUVO Surgical Light with a red
fault indication.

• Check to see whether the movement mechanism operates correctly.

The movement mechanism of the lights is tested by swivelling and rotating the light head in all
directions.

In the case of an error or defect please contact NUVO Inc. or a service dealer
authorised by NUVO Inc.

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Surgical lights

2.5 Cleaning, Sterilization, Disinfection

The operator must observe the requirements of the Infection Control Department for hygiene and
disinfection in the country of operation.

All outer surfaces of the NUVO Surgical Light, including the control unit, may be cleaned with
commercially available cleaning agents and alcohol-free disinfectants. Take care to prevent ingress of
cleaning liquids into the inner of the light.

Cleaning, Disinfection and Sterilization of Sterilizable Handles

The sterilizable handles are manufactured from heat-resistant and impact-resistant plastic. They may
be cleaned with mild, alkali-free cleaning agents that do not contain active chlorine. Cleaning materials
must be carefully rinsed with water. Alternatively the handles may be cleaned mechanically with heat
sterilization to a maximum temperature of 93°C in accordance with normal duty cycle times.

For disinfection of the sterilizable handles, we recommend products containing alcohol on an aldehyde
basis. The handles must be rinsed out before sterilization.

The handles may be steam sterilized. Recommended parameters for this are:
a.) Steam sterilization at 121 °C; 1.3 bar; 25 to 30 minutes
b.) Steam sterilization at 136 °C; 2.3 bar; 4 minutes

When filling the autoclave you must take care that the open side of the handles points downwards.
The handles must not be secured and must not come into contact with other objects to be sterilized.

Hot air sterilization is not recommended by NUVO Inc. If however this is necessary, the handles may
be loosely sterilized at 134 °C for 3 minutes.

Damaged handles must not be reused.

Note: Sterilizable handles are subject to natural wearing out. In general, service life consists of
approximately 250 cleaning cycles.

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 Verde
Surgical lights

3. OPERATION

3.1 Functions of the Control Unit

5 6

1
4

2 3

The following functions are controlled via the control unit:

1 - Switch on light, normal mode (white light)

press again: Endo mode (green light)
press again: switch light off

2 - Decrease illuminance

3 - Increase illuminance

4 - Fault display

In the case of an error please contact NUVO Inc. or a service dealer authorised by
NUVO Inc..

5 - (no function)

6 - (no function)

7 - Display of dimming level / illuminance

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Surgical lights

3.2 Adjustment of Light Field Size

The size of the light field may be adjusted by rotating the sterilizable handle.

• Rotating the handle clockwise increases the light field,

• Rotating the handle anticlockwise decreases the light field.

The surgeon must set the optimal field adjustment for the surgical procedure. An optimal
contrast is achieved when the field size is 1-2 inches (2 - 3cm) larger than the surgical field, so
that the sterile cover is also illuminated. This improves adaptation of the surgeon's eyes to the
complete field of vision.

3.3 Endo Mode

By pressing the 'Power' push-button twice on the control panel, the light switches to endo mode and
emits green light.

If the light is already switched on and is in normal mode (white light), pressing the 'Power' push-button
on the control panel once suffices for switching to endo mode.

The light cannot be dimmed in endo mode.

3.4 Replacement of the Sterilizable Handle

The sterilizable handle is released by rotating the handle counter clockwise. The newly sterilized
handle is reattached by rotating the handle clockwise until it reached the stop, at which point you
should apply a little extra rotational force to snug it up to the locking ‘O’ ring.

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Surgical lights

4. MAINTENANCE

4.1 Replacement of light sources

High-Power LED light sources are installed with an average service life in excess of 20,000 hours of
operation. With an average daily application duration, failure of the LED’s can be expected after 7 to 8
years at the earliest.

In order to guarantee flawless operation of the NUVO Verde NV4 and Verde NV3 Surgical Lights,
defective LED’s must be immediately replaced. In this case please contact you authorized NUVO Inc.
service technician.

Please note that any maintenance or replacement of components may only be

carried out by NUVO Inc. service or by skilled staff authorised by NUVO Inc.
Components may only be replaced with original NUVO components, as NUVO Inc.
cannot otherwise assume responsibility for faultless function of the surgical light.

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Surgical lights

4.2 Mechanical Adjustment Points

4.2.1 Overview of Adjustment Points

B1 B2
B2
B1
H
H
F
F

B4
B4

B3
B3

B1........ Adjusting screw for brake adjustment of bracket arm (see chapt. 4.2.2)

B2........ Adjusting screw for brake adjustment of spring arm (see chapt. 4.2.2)

B3........ Adjusting screw for brake adjustment of cardanic joint (see chapt. 4.2.2)

B4........ Adjusting screw for brake adjustment of light head (see chapt. 4.2.2)

F ......... Adjusting screw for adjusting the spring-force of spring arm (see chapt. 4.2.3 and
mounting instructions for the spring arm)

H ........ Adjusting screw for adjusting height restriction of spring arm (see chapt. 4.2.4 and
mounting instructions for spring arm)

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Surgical lights

4.2.2 Brake Adjustment

Required tools:
• Slot-head screwdriver, large
• Allen key, 4 mm

The braking action of individual joints must be so adjusted that the light head stays
in the desired position.
If a supporting arm of the operational light moves away, the corresponding braking
screw must be tightened.

Brake Adjustment of Bracket Arm (adjustment point B1)

The movability of the bracket arm is adjusted via

the brake screw (1 slotted screw per bracket
arm)
The braking effect is increased by rotating
clockwise.
The braking effect is decreased by rotating
anticlockwise.

Brake Adjustment of Spring Arm (adjustment point B2)

The movability of the spring arm is adjusted via

the brake screws (3 Allen screws, 4 mm).
The braking effect is increased by rotating
clockwise.
The braking effect is decreased by rotating
anticlockwise.

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 Verde
Surgical lights

Brake Adjustment of Cardanic Joint (adjustment point B3)

The move ability of the cardanic joint is adjusted

via the brake screw (Allen screw: 4 mm).
The braking effect is increased by rotating
clockwise.
The braking effect is decreased by rotating
anticlockwise.

Brake Adjustment of Light Head (adjustment point B4)

The move ability of the light head is adjusted via

the brake screw (Allen screw: 4 mm).
The braking effect is increased by rotating
clockwise.
The braking effect is decreased by rotating
anticlockwise.

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Surgical lights

4.2.3 Adjusting the spring-force of spring arm

If the spring arm with light head does not stay in the desired height position, the
spring load resistance must be adjusted.

4.2.3.1 Adjusting the Spring-Force of Spring Arm for Standard Cardanic

The lateral opening for adjustment of spring-force

is located on the light head side of spring-arm
behind the cover.
Press both plastic covers apart by carefully
levering with two small screwdrivers within both
grooves.

Remove plastic covers.

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Surgical lights

Move the spring-arm up and down, until the

adjustment nut appears in the opening.

Turn the adjustment nut with the metal pin

provided, until
- the spring-arm with light head can be moved in
all directions with equal force
- and the light head remains stable in every
position
Turning downwards (to „ - “) reduces the spring-
force.
Turning upwards (to „ + “) increases the spring-
force.

1. Press together both spring cover plates by

hand.
2. 1. 2. Then fit both plastic covers in sequence and
press tight until they are heard to snap in
place.

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Surgical lights

4.2.3.2 Adjusting the Spring-Force of Spring Arm for Flat Cardanic

Loosen the fixing screw and remove the round

cover.

Push the spring-arm upwards until the adjustment

nut appears in the opening.

Turn the adjustment nut with the metal pin

provided, until
- the spring-arm with light head can be moved in
all directions with equal force
- and the light head remains stable in every
position
Turning downwards (to „ - “) reduces the spring-
force.
Turning upwards (to „ + “) increases the spring-
force.

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Surgical lights

4.2.4 Adjusting the Height Restriction of Spring Arm

In order to avoid collision with other components, vertical adjustment of the spring
arm must be confined.

The lateral opening for height restriction

adjustment is located on boom side of the spring-
arm behind the cover.
Press both plastic covers apart via careful levering
with two small screwdrivers within both grooves.

Remove plastic covers.

Turn the adjustment nut with the metal pin

provided, until the distance between the ceiling
and the arm in highest position is 3 cm.
Turning downwards reduces the height
movement.
The adjustment nut can come off the
screw thread if the nut is screwed in the
wrong direction. - So check the height
restriction regularly, if necessary
change the direction of adjustment.

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Surgical lights

4.3 Spare parts

4.3.1 Sterilizable Handle

Verde NV3/NV4 handle for Surgical Light without Control Button ................... S2X00137
Verde NV3/NV4 handle for Surgical Light with Control Button ........................ S2A00074

4.3.2 LED Boards

Replacement of LED boards may only be carried out by an authorized NUVO service technician.

5. DECLARATION OF MANUFACTURER

Manufacturer's declaration with respect to electromagnetic compatibility

The light has been inspected with regards to electromagnetic environments commonly occurring in
Operating Rooms. The light may be operated without adverse effects.

Functional impairment of other devices during operation of the light is not to be expected.

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Surgical lights

6. TECHNICAL DATA

6.1 Lighting Data

Verde NV4 Verde NV3

Central luminance level at 1 m distance 80,000 - 160,000 lux 59,000 – 120,000 lux

Dimming range 50-100 % in 8 stages 50-100 % in 8 stages

Focusable size of light field dia at 1 m distance 8-12 in (210–300mm) 8-10.5 in (210–270mm)
0 0
Colour temperature 4,700 K 4,700 K

Colour rendering index [Ra(1-8)] >95 >93

Red rendering index [R9] 96 92

Radiation in direction of operation field 2 2
325 W/m 325 W/m
(at 100,000 lux)
Switching for endoscopic illumination green light green light

Service life of light sources > 20,000 hrs. > 20,000 hrs.

6.2 Electrical data

Verde NV4 Verde NV3
Primary mains voltage at Verde Powerbox 90- 90-250 V AC (Min./Max.), 90-250 V AC (Min./Max.),
250 VAC 50-60 Hz 50-60 Hz
22-31 V AC (Min./Max.) 22-31 V AC (Min./Max.)
Primary mains voltage at Verde Powerbox 22-
50-60 Hz 50-60 Hz
31AC 24-44DC
24-44 V DC (Min./Max.) 24-44 V DC (Min./Max.)
Total current input light head 5-6 A 5-6 A

Total power input light head 160 W 110 W

Mains voltage of light head 28 V DC 28 V DC

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Surgical lights

6.3 Mechanical data

Verde NV4 Verde NV3

Dimensions of light head 31.5x28in (800x720mm) 30x30in (770x770mm)

Individual light 65in (1,650mm) 65in (1,650mm)

Working radius of light Double light 59/65in (1,500/1,650mm) 59/65in (1,500/1,650mm)
head
59/65/71in 59/65/71in
Triple light
(1,500/1,650/1,800mm) (1,500/1,650/1,800mm)
Height adjustment of spring arm 46.5in (1,180mm) 46.5in (1,180mm)

Weight of light head 45 lbs (20.5 kg) 34 lbs (15.4 kg)

6.4 Classification
Product class according to Medical Devices Directive of
I
the European Community 93/42/EC
Protection class of powerbox I

Protection class of light head III

Mark of conformity CE

Protection category of the light head IP54

6.5 Interfaces
Digital interface for OR Management Systems RS 232
ZigBee Standard
Wireless radio signal for wall control unit
(IEEE 802.15.4)
Option: Integrated support for SD / HD camera yes

NUVO Contact Information:

NUVO Inc.
5368 Kuhl Road
Erie PA 16510-4703

Phone: (814) 899-4220

Fax: (814) 899-1410
Website: www.nuvosurgical.com
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