GYNAECOLOGICAL
VARIABLE HEIGHT
EXAMINATION
COUCH
INSTRUCTIONS FOR INSTALLATION,
USE AND MAINTENANCE
MO01037
INDEX:
- EC declaration of conformity ……………………………………………………………….……… 1
- Warranty certificate. ……………………………………………………………….…………..……… 2
- General provisions ………………………………………………………………….…………………… 3
Presentation of the manual
Customer support service
Conventions
- Safety …………………………………………………………………………………………………....……. 4
General provisions
- Introduction …………………………………………………………………………………………...…. 5
Technical presentation
Identification ..……………………………………………………………………………………………….… 6
- General description …………………………………………………………………………………..... 7
Name of the parts
Technical features …………………………………………………………………………………………..... 8
Materials used ……………………………………………………………………………………….………… 9
Functional check …..…………………………………………………………………………………………. 10
Disinfection
Assembly ……………………………………………………………………………………………….………. 11
- Installation ………………………………………………………………………………………….………. 12
Transport and handling
Functional check
Operation and use ……………………………………………………………………………………………. 13
- Maintenance ………………………………………………………………………………………………. 14
Periodic verification
Provision and storage….……………………………………………………………………..……………… 15
Scrapping
EC declaration of conformity
Released by:
CALDARA SRL
VIA TRIESTE 31 / B
22036 ERBA, COMO
ITALY
PH. +39 031.640896
info@caldarasrl.it
A - I declare under the sole responsibility of the company that the following products are safe in the
conditions of common use in compliance with the instructions and that measures have been taken to
ensure the conformity of all the products that have been put on the market with the basic requirements of
the directives related to paragraph "B".
Product Name: GYNAECOLOGICAL VARIABLE HEIGHT EXAMINATION COUCH
Code: MO 01037
B - The characteristics of this product are in compliance with the technical parameters related to them and
indicated in the DDM 93/42 / CEE which establishes the technical parameters of the health products and
the CE labelling requests.
Compliance was assessed with the procedure described in DDM 93/42 / EEC, Annex VII.
NOTE - This CE declaration of conformity also applies to all applicable accessories approved by the
manufacturer.
Date and place of release: Erba, 02/01/2020
Claudio Febbi
CEO Caldara s.r.l.
1
Warranty certificate
This certificate must be kept until the expiry date.
It must be presented every time a technical intervention is necessary, accompanied by the invoice, tax
receipt, delivery note or any supporting document showing the name of the retailer and the date of
purchase.
The user who is unable to produce these documents will lose all the warranty rights.
The warranty starts from the date of purchase shown on the invoice, receipt or delivery note and it is valid
for 24 months for the moving and electric parts, 36 months for the product structure.
The guarantee refers to the replacement or free repair, within the established terms, of the components of
the appliance which, at the discretion of the manufacturer, were found to be defective at the origin due to
manufacturing defects. This warranty does not cover:
_ transport faults (dents, scratches and similars);
_ damage due to falls;
_ damage caused by carelessness, negligence, inability to use the product, tampering and repairs carried
out by unauthorized personnel;
_ damages due to incorrect installation; if this is carried out by the user or by unauthorized personnel;
_ damages caused by insufficiency or inadequacy of the electrical system or alterations deriving from
environmental, climatic or other conditions, as well as damage caused by phenomena that do not depend
on the normal operation of the appliance;
_technical interventions concerning the installation of the appliance and the connection to the power
supply systems;
_ home repairs for convenience checks or alleged defects. If requested, the user will have to pay to the
person in charge a contribution previously estimated in advance with the intervention;
_ordinary maintenance;
_whatever may be normal decay for use.
However, product replacement is excluded.
The warranty intervention can be refused when the product has been modified or transformed in any way.
The restoration of the appliance will be carried out within the time limits compatible with the
organizational requirements, by authorized technicians, upon request by the user to the retailer or directly
to the manufacturer.
In the event of home intervention, the user is required to pay the fixed fee for transfer fees.
If the appliance is repaired at the retailer or at the manufacturer, the transport costs and the relative risks
will be charged to the user.
Warranty repairs do not result in an extension of the warranty itself.
Parts replaced under warranty remain property of the manufacturer.
No one is authorized to change the terms and conditions of the warranty or to issue other verbal or written
ones. The manufacturer declines all responsibility for any damage, of any nature, that may directly or
indirectly derive from persons, animals or things resulting from failure to comply with all the instructions
contained in this manual concerning, in particular, the installation warnings , use and maintenance of the
appliance or in any case improper use.
The manufacturer is also not responsible for any damage caused to people, animals or things due to
breakdown or forced suspension of use of the equipment. The Court of Como has jurisdiction for any
dispute.
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General provisions
Presentation of the manual:
This manual is an integral part of the article.
Carefully read the warnings and instructions contained in this manual as they provide important
information regarding SAFETY OF USE AND MAINTENANCE.
The descriptions and illustrations provided in this publication are not binding.
CALDARA S.R.L. reserves the right to make changes that it deems appropriate for the purpose of
improvement, without committing to update this documentation.
The illustrations and images contained in this manual are intended as examples only and may differ from
practical situations.
The manufacturer assumes no responsibility for direct or indirect damages, including loss of profits, or for
any other damage of a commercial nature that may result from the use of the product that does not
comply with what is described in this manual.
Customer assistance service:
Customer support and product support are important aspects of our corporate structure.
We are at your complete disposal for further information on the use and maintenance of this product.
(info@caldarasrl.it)
Conventions:
The following graphic symbols have been used in this manual:
WARNING! It is placed before certain procedures. Failure to comply may damage the
item.
WARNING! It is placed before certain procedures. Failure to comply may damage the
operator, the patient or the article.
3
Safety
General provisions:
WARNING! Improper use and maintenance can cause damage to people and property.
WARNING! NOTICE FOR BLOOD DISEASES: to reduce the risk of exposure during the use of
the chair, follow the maintenance instructions given in this manual, in addition to the provisions
on the safety of personnel prepared by the head of the Emergency Medical Service.
Operators must carefully read this manual, follow the instructions it contains and become familiar with the
correct procedures for using and maintaining the product.
Use and maintain the item only as prescribed in this manual and use only spare parts and assistance
CALDARA S.R.L.
Keep this manual for consultation and in support of staff training.
Transfer it with the product in case of sale or transfer to new users.
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Introduction
Technical presentation:
The structure is made of Fe360 metal for furniture; its height adjustment is by means of an electric actuator
(motor) with 6000N power and pedal control.
The very solid base is made of 50x25x2 oval tubular; the upper frame in rectangular tubular 50x20x1.5. Its
rotation points are mounted on self-lubricating bushings; during movement the bed does not undergo any
antero-posterior movement. The headboard is adjustable by gas spring (cylinder) power 600N maximum
inclination 60 ° positive and 10° negative. The entire structure is painted with white epoxy powder. The
high density padding is covered with class 1 IM fire retardant coated fabric (skai), washable with normal
detergents on the market. The roll holder is included and there are 4 adjustable feet which guarantee
greater stability.
Reference standards
The article was designed and built by CALDARA S.R.L. in compliance with the safety requisites foreseen by
the directive 93/42 / CEE of 14.06.93 (class I) and s.m.i. (Directive 2007/47 / EEC) concerning medical
devices.
Intended use
_Type of device: examination bed electrically height adjustable for examinations and therapeutic
treatments in ambulatory and hospital environment. INDOOR USE.
_Environmental setting: hospitals and clinics in application environments 2 and 5. The room must be
equipped with an electrical system in compliance with the regulations in force.
_ Staff assigned to use the product: specialized operators and doctors.
_ Supervision and responsibility: the bed must be used under the supervision of a doctor.
_Warning: the bed cannot be used in a potentially explosive atmosphere.
_Use limitations: the bed can only be used as described in this manual.
Environmental limits of use
The environmental conditions of use of the chair must follow these indications:
_Temperature: (0 to 50) C °
_Humidity: 10% -90% (not condensed)
Expected life
The bed has been designed to work without danger or risk to things or people, within the limits and
conditions defined in this manual for a period of 10 years, after which replacement is recommended.
Correct functioning is guaranteed only by contacting the manufacturer or retailer whenever a fault occurs
and in accordance with the instructions contained in this manual.
Manufacturer
The article described in this manual is produced by:
CALDARA S.R.L. Via Trieste 31/B 22036 Erba (CO) Italy PH +39 031 640896 info@caldarasrl.it
www.caldarasrl.it
5
Identification:
WARNING! it is forbidden to remove for any reason whatsoever label on the product.
The item can be identified by the label on the product
following data is reported:
_Name and address of the manufacturer
_CE mark
_Article model
_Serial number
The electrical devices can be identified from the respective labels where the following data are reported:
Control unit:
_Name and address of the manufacturer
_Article model
_Serial number
_Production date
_Functioning
_Max. Consumption
_IP protection degree
_CE mark
_Special waste
Applied part (control panel / pedals)
Class: Type B (Item Model / Serial Number)
Control panel Pedal board
6
General description
Component names:
1_Base
2_Upper floor
3_Head / backrest
4_Linear actuator
5_Handle for headboard adjustment
6_Seat
7
5 4 3 2 1
6
Technical features:
8
Materials used:
_ painted and galvanized steel for the metal structure;
_ top in wooden material, high density foam covered in washable fireproof class 1IM skai for the padded
top;
_ electric linear actuator with control unit and control devices for adjusting the upper floor;
_ gas spring for headboard adjustment;
_ bolts in galvanized steel.
9
Functional verification:
WARNING! This check must be repeated periodically to verify the efficiency of the
product.
Before using the product:
perform the "periodic check" provided in the Maintenance chapter.
Sanitising:
WARNING! Use neutral non-corrosive products available on the market. Sanitising agents
can be corrosive.
Carefully read the instructions provided by the manufacturer of the sanitising agent for the specific
application.
It is very important to follow the specifications concerning concentration, temperature and reaction times;
changing one of these characteristics can cause damage to the product and alter its characteristics.
Depending on how the chair is used, the user will establish useful sanitation intervals.
10
Assembly:
There are no parts to be assembled. Below there is an indicative drawing of how the product is
assembled.
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Installation
Transport and handling:
WARNING! The lifting and handling operations must be carried out by specialized
personnel trained in this type of operation.
It is necessary to use means suitable for the transport and handling of this product such as manual or selfpropelled forklift trucks, taking care to respect the precautions and rules for safety at work.
The product must be installed and used in environments suitable for its use, away from any atmospheric
agents capable of compromising its correct use and functioning.
At the time of delivery or collection it is necessary to check that the contents are intact and that the
equipment made for its use is also complete; only after carrying out these checks is it possible to eliminate
the packaging in disposal and collection places of the recycled material.
If the item is damaged during transport, retain the packaging and contact the carrier within 48 hours of
delivery.
Functional verification:
WARNING! This check must be repeated periodically to verify the efficiency of the
product.
Before using the product:
perform the "periodic check" provided in the Maintenance chapter.
If the check fails, contact your dealer or CALDARA SRL and take the chair out of service;
in case of a positive result, use the product after observing the points described above.
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A B
A B
Operation and use:
1_Place the bed on a flat non-yielding floor.
2_the space surrounding the bed must be free and allow for adjustment and maintenance operations.
WARNING! always before seating the patient if the product is equipped with wheels, check
that they are locked or raised from the ground.
WARNING! the power cable must be adequately protected and must not hinder the
operator.
WARNING! When moving the bed, it is necessary to check that you have unplugged the
power cord from the wall socket; re-evaluating the previous points.
3_use one of the supplied controls to adjust the upper deck.
13
Maintenance
Periodic check:
It is necessary to inspect the product at least once a year.
An inspection means a visual search for any damage that could compromise the integrity and proper
functioning of the article. You must check:
_ integrity of the power cord and plugs;
_ correct power cable connection;
_tightening of screws;
_ correct functionality;
_correct insertion of any accessories.
WARNING! If damage is detected, immediately place the product out of service until it is
repaired and put back into service.
WARNING! Any repairs and efficiency improvements are advised to be carried out by
specialized technical personnel of the sales or assistance service.
Cleaning:
we recommend an accurate and periodic general cleaning of the product for a longer and better duration.
WARNING! It is recommended NOT to use: thinners, alcohol or petrol, aggressive and
abrasive detergents.
Use water and neutral soap, rinse with a damp cloth and dry completely. This is an operation to be
performed when necessary or at least every 15 days.
14
Shelving or storage:
In the event of provision or storage, the following instructions must be followed:
_pack the product;
_position it on a flat and safe surface;
_must be in a dry place and away from the sun;
_grease the moving parts which could be damaged in case of drying;
_do not overlap any other item to the one set aside or stored.
Scrapping:
In case you decide not to use this product anymore, you need to:
_ make it inoperative;
_make any parts that could cause dangers harmless.
In the event that this product is to be scrapped, it is necessary:
_evaluate the classification of the asset according to the degree of disposal;
_separate the various components and place them in the appropriate collection centres;
_if considered special waste, dispose of according to the laws in force.
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CALDARA SRL – VIA TRIESTE 31B – 22036 ERBA (CO) ITALY – TEL/PH +39 031 640896 – P.IVA 01456450137
web link to www.caldarasrl.it
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