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MO095-GB 02/04/07

Operative Manual Rev.0 Page 1 of 27

Operative Manual
Installation – Use – Maintenance

Secondary Scialytic Lamp


for surgery
(Pentaled EV) IX Led
MOBILE + BATTERY
This manual is an integral part of the lamp according to the provisions
envisaged by the 93/42/CEE European Directive and successive
modifications and integrations.
The present manual must always accompany the Medical Device.

Via Monterosa, 18/20/22 – 20038 SEREGNO (Mi) ITALIA


Tel. +39 0362 325.709 Fax +39 0362 328.559
http://www.rimsa.it e-mail: info@rimsa.it

UNI EN ISO 9001:2000 UNI EN ISO13485:2004


CERT. n. 9120.RMS1 CERT. n. 9124.RMS2
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Introduction

Dear Client,
RIMSA congratulates you for having purchased a product from its range and invites you to read carefully
every part of the present Operative Manual, subdivided into installation, use and maintenance phases.
You will find all the necessary instructions for a correct use of the product within. Please observe the
warnings contained carefully, keep it unaltered and easy to find and be accessible to the operator. In
case of sale or transfer of the used apparatus, this manual and its attachments must always accompany it.
Rimsa can modify the content of the present Manual, without previous notice or further obligations, in
order to include variations and improvements.
The reproduction or translation of any part of the present manual is forbidden without the written
agreement of RIMSA.
We inform you that our Company remains completely at your disposal for further information and
clarifications of everything concerning the installation, use and maintenance of the product.

I The symbol to the side and used in the present manual is to be considered as advice and
requires particular attention.

The symbol to the side and used in the present manual means that it is to be considered
“compulsory” in order to install and use the device correctly.

There is a guarantee coupon attached (green page) to compile and return to RIMSA.
This coupon includes:
 the re-traceability of the Medical Device as required by the 93/42/CEE European
Directive.
 the Guarantee of the Product as shown on page 10.
 the confirmation of the complete reading of the manual by the installer as a
necessary and sufficient clause in order to be declared SUITABLE for the task of
installing the apparatus (having all the necessary information available for
installation with the use of the present manual).
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CONTENTS Page

Chapter 1 – General Information

1.1 Manufacturer identification data 5


1.2 Identification data of the apparatus, EC marking and re-traceability 5
1.3 Classification and destination of use of the device 7
1.4 Safety considerations (undesirable secondary effects) 8
1.5 Declaration of EC conformity 9
1.6 Guarantee 10
1.7 Technical assistance 11
1.8 Qualification of the personnel 11
1.9 Packing, Transport, Stockage and Characteristics of the installation premises 12

Chapter 2 – Electrical preparation of the premises

2.1 Electrical preparation of the premises 13

Chapter 3 – Installing the product

3.1 Installing bend pipe on base 13


3.2 Installing oscillating arm 14
3.3 Checking the installation and testing the scialytic operations before use 15

Chapter 4 – Using the apparatus

4.1 Description of the apparatus 16


4.2 Cleaning, disinfection, sterilisation 17
1.1.1
4.2.1 Cleaning and disinfecting the lamp 17
1.1.2
4.2.2 Sterilising the handle 17
4.3 Changing fuses 18
4.4 Technical data and performance of the apparatus 19

Chapter 5 – Maintenance

5.1 Calibrating the oscillating arm and bent arm 21


5.2 Battery maintainance 21
5.3 Extraordinary maintenance 22
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5.4 Repairing faults and anomalies 22


5.5 Ordinary spare parts list 22

Chapter 6 – Diagrams

6.1 General electrical diagram 23


6.2 Exploded drawings 24
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Chapter 1 – General Information

RIMSA does not assume any responsibility for eventual damage to people or things as a
result of failure to respect the safety regulations and recommendations contained in the
present document.

1.1 Manufacturer identification data

RIMSA P.LONGONI S.R.L.


Via Monterosa, 18/20/22
20038 Seregno – MILANO
ITALIA

1.2 Identification data of the apparatus, EC marking and re-traceability

The (PENTALED EV) IX LED mobile+battery secondary scialytic lamp for surgery is designed and
constructed according to the provisions of the 93/42/CEE directive.
Conformity is documented by the plate with the EC mark (portrayed below) and by the declaration of
conformity accompanying the present manual.

(PENTALED EV) IX LED mobile+battery scialytic lamp re-traceability plate

MEDICAL EQUIPMENT Seregno – Mi – Italia


MOD (a) SN (b)
Vac (c) Hz (d) W (e)
Lamp (f) Kg (g)
(h)
CLASSE I TIPO B
ET(j) (i)

Description of the fields:


(a) name of the model use (f) characteristics of the halogen lamp to
(b) series number (g) overall scialytic weight
(c) power tension (h) protections to use in the apparatus
(d) power frequency (i) date of construction (month/year)
(e) apparatus consumption (j) re-traceability label code

The plate is positioned on the tube of the horizontal arm near the central rotating element.
The re-traceability of the (PENTALED EV) IX LED Medical Device is guaranteed by the series number
positioned on the label in fulfilment of the internal company PO 7.5 Operative Procedure.

Description of the symbols on the plate, the product and in the present manual:
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Type B apparatus. Indicates the level of protection against direct and indirect contact.

Graphic symbol confirming the EC product mark.

Symbol indicating the manufacturing date (month and year).

Protection device: fuses employed in the device.

Upper side of the packing.

Maximum number of stackable packages.

Fragile package.

Unsuitable package in humidity.

Do not superimpose pallets over the packages.

Package weight.

Danger of burning.

I Attention → ADVICE

Warning → COMPULSORY

All electrical and electronic products should be disposed of separately from the municipal
waste stream via designated collection facilities appointed by the government or the local
authorities.

1.3 Classification and destination of use of the device


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Classification according to a particular regulation (CEI EN 60601-2-41 regulation section 2)


Secondary scialytic lamp for surgery (treatment lamp): single lamp in the patient zone that assures an
adequate illumination at the centre to illuminate the patient’s body locally. It is designed to be used in the
operating theatre, for treatments and diagnoses that can be interrupted without danger to the patient in
case of lighting failure.

Classification of the medical devices in terms of the 93/42 EEC directive (attachment IX)
Short-term, active and not invasive medical device destined for local illumination of the patient. In terms
of the above, the device is considered as falling into class I, according to rule 1.

Classification according to a general regulation (CEI EN 60601-1 regulaton article 5)


 On the basis of the type of protection against electrical danger: class I apparatus
 On the basis of the type of protection against direct or indirect contact: type B apparatus
 On the basis of protection against penetration of water: ordinary apparatus
 On the basis of the level of safety of use in the presence of an inflammable anaesthetic mixture with
air or oxygen or hydrogen protoxide: apparatus considered not suitable for use with the elements
describe above.
 On the basis of the conditions of use: apparatus for continuous functioning.

1.4 Safety indications (undesired secondary effects)


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 The incorrect use and non-observance of the precautionary measures reported here can provoke
serious accidents. You must, therefore, understand the functions of the (PENTALED EV) IX LED
scialytic lamp using these instructions for installation, use and maintenance.

 The lamp is not designed to function in a zone with risk of explosion.

 Do not look directly at the lit lamp and do not insert reflecting objects in the way of the rays. There
is the danger of blinding due to the high potency of illumination.

 The distance between the surface of emission of the light of the lamp and the surface of the patient
should not be less than 80 cm so as to guarantee an efficient illumination.

 The lamp must not be switched on if the closure glass or the filtering system (parabola) is damaged
or broken. Thermal radiation may arrive in the operation area and the tissue of the wound of the
surgical intervention might overheat and dry up. There is indeed the danger of necrosis of the tissue
with prolonged use over time.

 Do not place any objects on the body of the lamp nor hang objects on the arm or the body of the lamp
because, in this way, a safe position cannot be guaranteed and the danger exists that these objects
might fall into the operation area. The weight of heavy objects (the weight of the body of a person)
can damage the apparatus.

 The head of the lamp must not be covered while functioning because this way the thermal exchange
with the environment is prevented and the lamp might overheat.

 Avoid collisions with the mobile+battery arms and the body of the lamp. The lamp might be
damaged with a violent collision or pieces of paint might break off and fall into the operating field of
the patient zone.

 The main switch must be used to remove the tension of the electrical plant of the premises to the
scialytic apparatus for any kind of maintenance.

 Whenever changing the burnt-out bulb immediately, be particularly careful to avoid burning, which
would be caused to the user’s accidental contact with the high temperature parts of the lamp and the
bulb to be changed.

1.5 Manufacturer’s declaration of conformity CE


The Company:
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RIMSA P. LONGONI S.r.l. Via Monterosa, 18/20/22 - 20038 SEREGNO (MI) - ITALIA
declares on its own responsibility that the Medical Illumination Device for surgical and diagnostic use:

(PENTALED EV) IX LED


MOBILE+BATTERY

ATTACCARE
ETICHETTA

constructed by RIMSA P.LONGONI S.r.l., conforms to the Attachment VII of the 93/42 EEC Directive
of June 14th 1993 and applied in Italy by the Legislative Decree N° 46 of February 24 th 1997 and
successive variances moreover, it is in conformity with the following safety regulation EN 60601-2-41.

Classification with reference to article 9 and Attachment IX of the 93/42/CEE Directive


DURATION: Short term (Par.1 “Definitions”, art.1, paragraph 1.1, attachment IX)
DESCRIPTION: Non invasive Medical Device (Par.1 “Definition”, art.1, paragraph 1.2, attachment IX)
Active Medical Device (art.1, paragraph 1.4, attachment IX)
CLASS: I (Par.3 “Classification”, art.1, paragraph 1.1 Rule 1, attachment IX)

 Technical reference file Code RIM-FT007.


 The evaluation of conformity is developed in reference to article 11 of the 93/42 EEC Directive.
 The RIMSA Quality System conforms to the UNI EN ISO 9001:2000 and UNI EN ISO
13485:2004 regulations and is certified by the IMQ S.p.a. (certified CSQ n.9120.RMS1 and
9124.RMS2).

Name: Paolo Longoni


Position: Managing Director

1.6 Guarantee
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1. The product is covered by guarantee for a period of 12 months, including the electrical parts.
2. The guarantee initiates from the date of installation of the lamp at the client’s premises only and
exclusively if RIMSA personnel carry out the installation. In all other cases the guarantee starts from
the date of forwarding the lamp from the RIMSA store to the client.
3. In case of dispute, the date indicated on the “Transport Document” that accompanies the goods is
retained valid.
4. The reparation or substitution, under guarantee, of a detail, is undertaken for well-ascertained
manufacturing cause and at the unchallengeable judgement of the RIMSA Company. The guarantee
does not include the transfer of personnel, packing expenses or transport.
5. Components subject to normal wear are not included in the guarantee (non-exhaustive e.g. halogen
lamps, fuses, relays, ball-bearings etc.).
6. Not included in the guarantee:
- damage and defects due to installation errors;
- damage or faults caused by carelessness, negligence, abnormal use of the apparatus or other
causes not attributable to the manufacturer;
- interventions for presumed defects or convenience checks.
7. The right to the substitution of the complete Lamp is not recognised.
8. The guarantee does not lead to any direct or indirect compensation of any kind towards people or
things due to the inefficiency of the lamp.
9. RIMSA does not accept responsibility for faults or damage caused by the improper use of the product
or upon which ordinary maintenance has not been practised or the elementary principles of good
maintenance have been neglected (negligence).
10. Compensation for the Lamp lock is not recognised.
11. The guarantee is forfeited automatically whenever the lamp is mishandled, repaired or modified by
the purchaser or third parties not authorised by RIMSA.
12. For interventions, the purchaser must apply to the retailer or the assistance centres indicated by
RIMSA.
13. The components substituted in guarantee must be restituted to RIMSA carriage free.
14. Failure to restitute leads to debiting the cost of the element to the applicant.
15. RIMSA does not accept returns from the final users.
16. Returns to RIMSA for repair must be managed by the retailer or the assistance centre chosen by the
final user in conformity with the Company PO 7.2 Operative Procedure.
17. Returns to RIMSA must be documented and authorised in conformity to the internal procedure.
18. Products returned to RIMSA must have the authorisation document attached at return and a document
describing the fault.
19. All the products for repair must be sent to RIMSA free port and adequately packaged (it is
compulsory to use the original packing).
20. The manufacturer does not consider himself responsible for the effects on safety, reliability and
performance of the apparatus if:
- montage, added calibration or repairs are not carried out by personnel previously authorised by
RIMSA;
- the electrical plant of the environment (premises) in which installation has taken place is not in
conformity with the CEI 64-8 regulations (regulations for electrical plant for premises utilised for
medical use) and similar regulations;
- the apparatus is not used in conformity with the usage instructions.
21. The green voucher completes the guarantee on the product and, besides, is important for the purpose
of re-traceability and as part proof of having read and understood the present manual.

1.7 Technical assistance


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For any requests, clarifications or interventions contact the numbers below.


Telephonic assistance is guaranteed from Monday to Friday, from 8.30 a.m. to 5.30 p.m.

RIMSA TECHNICAL ASSISTANCE OFFICE FOR CLIENTS


Via Monterosa, 18/20/22 – 20038 SEREGNO (Mi) ITALY
Tel. +39 0362 325.709 Fax +39 0362 328.559
http://www.rimsa.it e-mail: tecnico@rimsa.it

1.8 Qualifications of the personnel

The following table describes the life of the scialytic lamp in chronological order and the qualifications
requested by RIMSA.

Apparatus technical life phases Responsible operator qualification


RIMSA or qualified Installer/ Maintenance
Installation
operator
Use Authorised medical personnel
Ordinary maintenance RIMSA or company maintenance
RIMSA or qualified Installer/ Maintenance
Extraordinary maintenance
operator
Assistance RIMSA or authorised dealer

Demolition RIMSA, qualified Installer/ Maintenance operator

RIMSA does not accept any responsibility for eventual damage to people or
things as a result of employing unqualified operators.
Qualified Installer/Maintenance operator means a male or female person/or
male or female people who has/have completed a course at the RIMSA
company or has/have made an attentive study of the present manual and as
confirmation of this has/have returned the attached green guarantee voucher

1.9 Packing, Transport, Stockage and Characteristics of the installation premises


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The packing for the (PENTALED EV) IX LED mobile+battery model consists of one box:
Dimensions Weight
Packing Content LxDxH (Kg)
1 Scialytic lamp + Operative Manual 73x175x43 46

Transport is carried out by RIMSA or by any carrier as long as the following characteristics are respected:

Temperature (-20/+60)°C
Humidity (30/90) % (including condensation)
Atmospheric pressure (500/1060) h/Pa

Stockage (storage) of the packaged devices must take place in a dry place and at the following
temperature:

Temperature (+5/+40) °C
Humidity (30/90) % (including condensation)
Atmospheric pressure (500/1060) h/Pa

The premises designated for setting up the apparatus must have the following characteristics:

Temperature (+10/+40) °C
Relative humidity (30/75) %
Atmospheric pressure (700/1060) h/Pa

Before proceeding with installation, check that all the packages are present and in good
condition, without damage due to transportation and that the contents coincide with what


has been reported above.
Complaints will be considered only if the vendor or the forwarder is immediately advised.
Every complaint must be made in written form. The goods always travel at the risk and
danger of the purchaser.
Keep the original packing in case there is the need to return the lamp.

Chapter 2 – Electrical preparation of the premises


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 The preparatory masonry and electrical work for installing the Product is at the total
expense of the Final Client.

2.1 Electrical preparation of the premises

The work of preparing the electrical plant of the premises designated for medical use for
the electrical supply to the Product must be carried out safely according to good rules by
qualified personnel.
Qualified personnel means, as non-exhaustive examples, the following professional
figures:
Expert electro-technicians, qualified to exercise the profession of electrician

Before installing the scialytic lamp make sure of the following conditions:
 The electrical plant of the environment (premises) in which the installation will be carried out
must conform to the CEI 64-8 regulations (regulations for electrical plant for premises designated
for medical use) and the national laws and/or regulations in force.
 An electrician qualified to issue the certificate of conformation must certify the electrical plant.
 The check of the grounding must be certified, as foreseen in the regulation in force.
After making sure of the correspondence with the above-listed requisites, identify which of the following
types of electrical plant you are facing.

Chapter 3 – Installing the product

3.1 Installing bent pipe

Remove the bolt with washer from the bottom of the bent pipe. Insert
the cover of the pipe on the upper part paying attention not to damage
the painting. Fix the cover at approximately 15cm fixing screwing
without force (otherwise you risk causing undesired scratches on tube
1 painting) a single screw of the three screws placed on the collar (1).

IMPORTANT:
The battery is disconnected for the delivery. Remember to connect it
exactly.
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3
Using the bolt (1) previously unscrewed from the pipe, join the tube (3)
to the base (2) and lock the bolt with some turns. Insert the plug of the
2
lock of the pipe in the appropriate hole of the base.
1
Join the electrical contacts coming from base to those of the cover.
ATTENTION: Every six month you have to control the bolt is
loked.

1
Lock with force the bolt from the lower part using one pipe wrench (1)
or a similar tool (force of serration c.ca 60 Nm).

Lower the cover until the bottom of the base while the switch is in
frontal position and centred. Lock the three screws of the collar (1).

3.2 Installation oscillating arm

Join the electrical connectors (2) respecting the colours of the electrical
cables:
 yellow/green with yellow/green
 blue with blue
 brown with brown

Align the hinge (1) of the vertical oscillating arm with the bent tube (2).
Keep the parts to couple aligned on the same axis and align the hole of
the iron pin (3) with the threaded hole of the bent pipe.
Screw down the special screw with a mechanical key of 7 measure
until the end of the screw (torque force around 8Nm).
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In order to remove the detention of the arm, lower it and remove the
detention.
Close the hole with its own plastic plug attached in the equipment.

THE FUSE PROTECTION MUST BE INSERTED IN THE APPOSITE POSITION

ONLY AFTER

COMPLETING THE INSTALLATION (MECHANICAL AND ELECTRICAL) OF THE


SCYALITIC LAMP.
EARLY FUSE INSERTION MAY CAUSE THE LIGHT SOURCE SERIOUS DAMAGE.
NB: FOR LONG STANDSTILL PERIODS (GREATER THAN 15 DAYS) PLEASE
REMOVE THE SECONDARY FUSE (AT LOW VOLTAGE SIDE) FROM THE LAMP.

3.3 Checking the installation and testing the scialytic operations before use

The following notes are to be considered as compulsory during the phase of checking the
installation as it proves the correct verification of all the points indicated .
For this reason every single point should be looked at when treated together with the
guarantee sheet proving the correct installation of the device.
E.g.: Check the removal of the stop inserted in the oscillating arm ‫ڤ‬

Checking installation:

1 Check the removal of the stop inserted in the oscillating arm once installation is completed ‫ڤ‬

Check the supply tension on the transformer output terminals and verify that is between 17,5
2 ‫ڤ‬
and 18,5 Volt
3 Check the correct insertion of the halogen bulb (flush on the lamp-holder and on the vertical) ‫ڤ‬

Check the light emission glass of the head of the lamp


In case the light emission glass is damaged or broken, fragments of glass might fall into the
4 ‫ڤ‬
patient zone. The lamp must be turned off immediately and no longer used until the fault has
been eliminated.
Check that the mechanical movement element functions perfectly.
5 Check the mechanical functioning of the lamp with orientation and rotation movements of the ‫ڤ‬
mechanical movement element.
6 Check that the angle movement of oscillating arm is around 10 degrees and then stop ‫ڤ‬
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Scialytic test:

1 After turning on, the lamp should supply light ‫ڤ‬

Tension read at contacts (17,5<V1.2<18,5):


Position the head at 1m from the protective glass of the
luminous intensity probe and, identifying the maximum
2 luminous intensity zone (centre of the luminous band),
klx reading (I = 60 klx ± 5%):
position the luminous field at maximum intensity by
rotating the handle that can be sterilised.

Stamp and signature of the installer

__________________________________

Chapter 4 – Using the apparatus

4.1 Description of the apparatus


Model (PENTALED EV) IX LED
mobile+battery is a cold light
observation lamp.

The light beams, fruit of mathematical


elaborations of the reflecting mirrors,
allow to obtain a shadowless lighting
system and of depth. The reflector
rotates on both axes so as to make it
more flexible. The vertical movement is
of approximately 150 cm. the balance
of the vertical arm is obtained through a
compression spring, which makes the
lamp light while moving and stable in
its position.
Focusing the beams is made possible
using the sterilizable handle until beams
emitted from every single inner optical
group are concentrated.
The lamp can be switched on pushing
the green button on the cover of the
base (ON position: the battery group is
supplied and keeps on recharging the
batteries). To light the lamp it is
possible to act on the key on the
keyboard with round membrane (I/0).
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1 Wheel base 2 Aluminium cover base 3 Bent tube


4 Vertical arm 5 Semi fork 6 Upper cap cover
7 Sterilised handle 8 Lock for transport 9 Power plug-in


The presence of electro-scalpels, defibrillators and other devices functioning at high
frequence can disturb the scialytic lamp. Their influence will be possibly detectable from
variations in luminous intensity.

4.2 Cleaning, disinfection, sterilisation

4.2.1 Cleaning and disinfecting the lamp

 Before proceeding to the cleaning operations, remove the supply to the lamp from the
main line switch dedicated to the scialytic lamp

All the parts of the lamp can be cleaned with ordinary detergents on all the external surfaces and can be
disinfected with ordinary disinfectants in use in the operating department (no corrosive liquids and
containing chlorine) using a soft wet cloth.


DO NOT pour the contents of detergent and disinfectant containers directly over the
lamp even with vaporisers and never spray liquids inside the head or clean the internal
reflecting parabola.

Only disinfectants authorised by the manufacturer should be used for use on the following materials: rigid
polyurethane (PUR), polyamide +glass fibre (PA6) white Teflon (PTFE), and epoxy-polyester based
paint.

4.2.2 Sterilising the handle

Simple cleaning: the handles that can be sterilised consist of thermo-hardened material, resistant to hear
and shock resistant. They can be cleaned with slightly alkaline cleaners without active chlorine. Remove
the detergent by rinsing with abundant water.
Alternatively the handles can be mechanically cleaned through thermal disinfection up to a temperature of
93°C for 10 minutes.
Disinfection: we advise alcohol or aldehyde based products for disinfecting the handles
Sterilisation: the handles can be sterilised with steam.
For sterilising, keep to the instructions contained in the following steam cycle sterilisation table

Type of steam cycle Steam cycle description


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Sterilisation Number of Sterilisation


Drying time
Temperature empty peaks time

121 °C 121 °C 2 15 min 30 min

134 °C
(if the handle has come into
134 °C 2 18 min 30 min
contact with infective agents -
BSE)
134 °C
(if the handle has not come into
134 °C 2 4 min 30 min
contact with infective agents -
BSE)

When the steriliser is loaded, check that the open part of the handle is turned downwards. The handles
must be positioned freely, avoid covering them with other accessories.
The handle should be sterilised whenever it is necessary and in always following any internal protocols or
national or local directives.


The handles that can be sterilised are subject to natural wear. Normally they last about
200 cleaning cycles. Damaged handles can no longer be used. The user must take into
account the demands of the competent national body on hygiene and disinfection.

The Rimsa Company does not advise hot air sterilisation. If, however, it becomes necessary, the handle
must be sterilised, unpacked, at 134°C for 3 minutes.
Handle disposal:
sterilise the now worn-out handle to avoid contamination and eliminate it according to the normal
procedures for non biologically infected materials.

4.3 Changing fuses

 Before proceeding to the operations of changing fuses, remove the supply to the electric
panel from the main line switch dedicated to the scialytic lamp

The fuses are placed on the cover of the slab. Unscrew the fuse and replace the out-of-order fuse with one
new with identical characteristics, respecting the face on the label.

Data on the fuses established by Rimsa:


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n° terminal Description Type of fuse Dimensions


1 On the line of the input phase T4A 5 x 20
2 On the line of the neutral input T4A 5 x 20
4 On the line of the output phase T10A 5 x 20

The fuses are located on the cover of the base. Unscrew the fuse and replace the out-of-order fuse with
one new with identical characteristics, respecting the face on the label.

4.4 Technical data and performance of the apparatus

(PENTALED EV) IX
Technical data on the light
LEDMobile+battery
Reflector in vacuum treated aluminium
Technology of the reflecting mirror
for covering metal

Elimination of heat from the bulb Radiators in a special alloy

Colour temperature [K] 4500 ± 5%

Illumination Ec at 1 m distance (head /probe) [klx] 100

Total irradiation in UV [W/m2] 0,002

Total maximum irradiation (visible and IR) [W/m2] 112

Irradiation / Illumination [m(W/m2)klx] 1,1

Index of chromatic yield Ra [-] 93

Diameter of the luminous field d10 and d50 [mm] d10=150, d50=90

Depth of illumination [mm] 750

Data on electrical connection

Primary alternate tension [ac Volt] 0, 230

Secondary alternate tension [ac Volt] 0, 18

frequency [Hz] 50/60

Power absorbed [W] 50 (110 in battery charge)

Electrical safety class I


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Protection against direct and indirect contact Type B apparatus

General data

Bulb holder Led 3W


Duration LED [h]
(this datum can vary on the basis of a supply tension
50.000
superior to that indicated, by tension peaks and the
frequency of use)
Autonomy in battery mode [h] 7

Dimensions

Lamp body diameter [cm] 40

Internal reflector diameter [cm] 9

Light emission surface [cm2] 572,2

Maximum rotation range [cm] 200

Maximum head vertical movement [cm] 146

Scialytic lamp weight [Kg] 46

Certificates
In conformity with the 93/42/CEE
directive

Chapter 5 – Maintenance

Ordinary maintenance of the apparatus consists of:

 changing the fuses in case of breakage (Paragraph 4.3)


 calibrating the oscillating arm (Paragraph 5.1)

5.1 Calibrating the oscillating and bent arm


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The lamp is sold already balanced and no further calibration is


1 necessary. If over time the oscillating arm with spring balance becomes
rigid or loose it is possible to intervene mechanically by adjusting the
compression of the internal spring.
Bring the oscillating arm to the highest position allowed and remove the
aluminium cover (1).

Insert a pin of 5mm maximum and rotate it anti-clockwise or clockwise


to increase or diminish the strength of the spring.
At the end of adjustment replace the cover in the original position.
After adjustment the balancing should be fluid.

For the regulation of the clutches on the rotation of


the arms it is necessary to act on the indicated M4x5
screws as shown in the drawing.
+

5.2 Battery maintenance

The battery group does not need any specific maintenance because all the batteries used are lead-sealed
and are based upon the modern technology of oxygen recombination.
This makes the lamp completely safe thanks to the loss of the electrolyte. The lamp can be used in any
position and does not need any further maintenance.
Charge/discharge cycles depend on the depth of discharge; however it is possible to calculate roughly
1000 charge/discharge cycles at 20-30% of discharge depth. The average lamp life of the battery group is
usually 4 years in stand-by.
If the storage takes place in a dry place and not in extreme conditions the battery maintains its charge for
approximately one year.
If you do not know the status of the battery and want to check its general conditions, it is necessary to
charge it at least 12 hours and to run it down at 50% of the highest luminous intensity, verifying that it
lasts at least 4 hours.

5.3 Extraordinary maintenance


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For extraordinary maintenance of the lamp the following points need checking:
 luminous intensity reduced by more than 30%: check that an opaque mist has not formed on the
internal surface of the glass protection with the evaporation of detergents penetrated inside the
head and evaporated due to the heat of the bulb.
 detachment of parts of the paint from the apparatus due to accidental collision with other objects:
these fragments can fall onto the patient zone during the use of the device.
For the cases mentioned above, contact the Manufacturer or the assistance centre nearest the Client
authorised by the Manufacturer.

5.4 Repairing faults and anomalies

n Problem Solution
Check the horizontally of the plate floor and the
1 The lamp does not hold its position adjustment of the frictional force
The lamp does not work Check the presence of the fuses inside the terminal
board and their condition.
2

Check the characteristics of the inserted fuses


The fuse keeps on burning
3 (paragraph 4.4)

4 The lamp flickers The electronic board or led are faulty

The luminous band on the operating Check the correct position of sterilizable handle.
5 field is not in focus

The lamp working thanks to the The charger does not work. The interior green light
6 battery runs down after one hour. does not switch on.
Batteries are exhausted.

5.5 Ordinary spare parts list

Description Ordering code

Led 3W Z100113

Handle that can be sterilised Z142166

Electronic board 9 LED Z2300602


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Chapter 6 – Diagrams
6.1 General electrical diagram

6.2 Exploded drawings


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