LINET GRACIELLA Parts list manual

User Manual and Technical
description
GRACIELLA
Gynaecological examination chair
D9U004GKC-0101
Version: 03
Date of publication: 2022-06

D9U004GKC-0101
2
Manufacturer:
BORCAD Medical a.s.
Fryčovice 673
739 45 Fryčovice
Tel.: [phone]
Fax: +420,312,522,668
E-mail: [email protected]
www.borcadmedical.com
Distributor:
LINET spol. s r.o.
Želevčice 5
274 01 Slaný
Tel.: [phone]
Fax: +420,312,522,668
E-mail: [email protected]
http://www.linet.com
Graciella
Gynaecological examination chair
Author: BORCAD Medical a.s.
Related links: www.linet.com
D9U004GKC-0101
Version: 03
Date of publication: 2022-06
Copyright © LINET, s.r.o., 2022
Translation © LINET, 2022
All rights reserved.
All trademarks and brands are the property of the appropriate owners. The manufacturer reserves the right to changes in the
contents of this manual that relate to the product´s technical regulations. It is for this reason that the contents of this manual may
indicate differences from the current manufacture of the product. Reproduction (including excerpts from this text) is permitted only
with the prior permission of the publisher. This text is subject to change due to technical developments. All technical data are rated
data are subject to construction and manufacturing tolerances.

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1 Symbols and Denitions .............................................4
1.1 Warning Notices..........................................................4
1.1.1Types of Warning Notices ........................................4
1.1.2 Structure of Warning Notices ...................................4
1.2 Instructions..................................................................4
1.3 Lists.............................................................................4
1.4 Symbols on a package................................................5
1.5 Symbols and labels on a chair ....................................6
1.6 Product Label with UDI ...............................................9
1.7 Audible alarm .............................................................10
1.8 Denition .....................................................................11
1.9 Abbreviations ..............................................................12
2Safety Instructions.......................................................13
3 Unpacking instructions ...............................................15
4Intended Use ...............................................................19
4.1 Intended use ...............................................................19
4.2 User population...........................................................19
4.3 Contraindications ........................................................19
5Product Description ....................................................20
5.1 Chair with footrests - without vertical adjustment........20
5.2 Chair with footrests - with vertical adjustment.............21
5.3 Chair with Goepel footrests - without vertical
adjustment .............................................................22
5.4 Chair with Goepel footrests - with vertical adjustment 23
5.5 Chair with Goepel footrests - with manual position
adjustment..............................................................24
6 Technical specication................................................25
6.1 Identication of Applied Parts (Type B) ......................25
6.2 Mechanical Specications (Graciella) .........................25
6.3 Environmental conditions(Graciella) ..........................26
6.4 Electrical Specications (Graciella).............................26
6.5 Electromagnetic Compatibility.....................................26
6.5.1 Instructions and manufacturer's declaration - elec-
tromagnetic radiation .............................................27
6.5.2 Instructions and manufacturer's declaration - elec-
tromagnetic immunity ............................................27
7Use and Storage Conditions.......................................28
8Scope of Delivery and Product Variants....................29
8.1 Delivery .......................................................................29
8.2 Scope of Delivery........................................................29
8.3 Graciella Variants........................................................29
9Entry into Operation ....................................................30
9.1 Potential Equalisation ................................................. 32
9.2 Before use...................................................................33
9.3Transport.....................................................................33
10Mains Power Cable ....................................................34
11 Manipulation ...............................................................35
11.1 Control Elements.......................................................36
11.1.1 Hand controller (part of electrically operated foot-
rests / Goepel footrests).........................................37
11.1.2 Foot Controller for the chair height adjustment
(optional) ................................................................38
11.2 Chair Positioning ......................................................39
11.2.1 Chair height ............................................................39
11.2.2 Seat section ...........................................................40
11.2.3 Backrest ................................................................41
11.2.4 Footrests/Goepel footrests adjustment (only for
electric vertical movement of the footrests)............42
11.2.5 Manually adjustable Goepel footrests (vertically)... 43
11.2.6 Position for patient examination .............................44
11.2.7 Patient mounting position.......................................45
11.2.8 Straight position......................................................46
11.2.9Trendelenburg Emergency Position ....................... 47
11.2.10Adjusting the straight position using the buttons
for adjusting the height of the chair and the back
part .............................................................48
11.2.11Trendelenburg emergency position adjustment
using the backrest and seat section adjustment
buttons........................................................49
12Mandatory optional equipment ................................50
12.1 Footrests - without vertical adjustment ....................51
12.2 Footrests - electrically operated ................................ 52
12.3 Goepel footrests (hereinafter only Goepel)- without
vertical adjustment .................................................53
12.4 Goepel footrests (hereinafter only Goepel)-
electrically operated ...............................................54
12.5 Goepel footrests (hereinafter only Goepel) –
manual position adjustment ................................... 55
12.6 Bowl holder L ...........................................................56
12.7 Bowl holder R............................................................56
12.8 Hand controller L ......................................................57
12.9 Hand controller R ......................................................57
13Optional equipment ..................................................58
13.1 Step L........................................................................59
13.2 Step R .......................................................................59
13.3 Eurobar L ..................................................................59
13.4 Eurobar R..................................................................59
13.5 Lamp L .....................................................................60
13.6 Lamp R .....................................................................60
13.7 Paper roll holder L.....................................................60
13.8 Paper roll holder R ....................................................60
13.9 Castors......................................................................61
13.10 Patient surface extension........................................ 62
14Accessories ...............................................................64
14.1 Infusion stand............................................................64
14.2 Eurobar holder ..........................................................65
14.3 Headrest (pillow) ....................................................... 65
14.4 Physician's chair —ergonomic..................................65
14.5 Physician's chair — ergonomic, adjustable by feet .. 65
14.6 Physician's chair — height-adjustable, manual
locking....................................................................65
14.7 Short cover................................................................66
14.8 Long cover ................................................................66
15Cleaning/Disinfection ................................................67
15.1 Cleaning (Graciella) .................................................67
15.1.1 Daily Cleaning........................................................ 67
15.1.2 Full Cleaning and Disinfection ...............................67
16Troubleshooting.........................................................69
17Maintenance ...............................................................70
17.1 Regular maintenance................................................ 70
17.2 Spare Parts ...............................................................70
17.3 Safety technical inspections......................................70
18Disposal .....................................................................71
18.1 Environmental Protection.......................................... 71
18.2 Disposal ....................................................................71
18.2.1 Within Europe ........................................................71
18.2.2 Outside Europe ......................................................71
19Warranty......................................................................72
20Standards and Regulations .....................................72
Contents

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1Symbols and Denitions
1.1Warning Notices
1.1.1Types of Warning Notices
Warning notices are differentiated by the type of danger using the following key words:
► WARNING warns about the risk of physical injury.
► CAUTION warns about the risk of material damage.
► DANGER warns about the risk of fatal injury.
1.1.2Structure of Warning Notices
SIGNAL WORDS!
Type and source of danger!
► Measures to avoid the danger.
1.2Instructions
Structure of instructions:
► Perform this step.
Results, if necessary.
1.3Lists
Structure of bulleted lists:
■ List level 1
□ List level 2
● List level 3

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1.4Symbols on a package
FRAGILE, HANDLE CAREFULLY
THIS WAY UP
PROTECT FROM MOISTURE
PAPER RECYCLING SYMBOL
DO NOT USE A HAND TROLLEY HERE

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READ THE USER MANUAL
STOP BUTTON (PRESS TO INTERRUPT THE CHAIR POSITION)
SAFE WORKING LOAD
MAXIMUM WEIGHT OF PATIENT
WEIGHT OF CHAIR
POSSIBLE RISK
APPLIED PARTS TYPE B
ONLY SUITABLE FOR INDOOR USE
MEDICAL DEVICE
UNIQUE DEVICE IDENTIFIER
CE MARKING
REFERENCE NUMBER (PRODUCT TYPE DEPENDING ON THE CONFIGURATION)
BORCAD Medical a.s.
Fryčovice 673, 739 45
Czech Republic
www.borcadmedical.com
GKC0002
230 VV: , 50/60Hz
P: max.
IP X4
370 VA
int. on/off: max 2/18 min
SN
REF
GRACIELLA
(01)8596307000235
(11)991230
(21)GKC0002
MODEL:
4BCGKC-3FL00C1
=
=
=
180 kg
(396 lb)
190 kg
(418 lb)
120 kg
(264 lb)
2020-01-31
SB-GKC-000
UDI
MD
BORCAD Medical a.s.
Fryčovice 673, 739 45
Czech Republic
www.borcadmedical.com
GKC0002
230 VV: , 50/60Hz
P: max.
IP X4
370 VA
int. on/off: max 2/18 min
SN
REF
GRACIELLA
(01)8596307000235
(11)991230
(21)GKC0002
MODEL:
4BCGKC-3FL00C1
=
=
=
180 kg
(396 lb)
190 kg
(418 lb)
120 kg
(264 lb)
2020-01-31
SB-GKC-000
UDI
MD
1.5Symbols and labels on a chair

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SERIAL NUMBER
MANUFACTURER
DATE OF MANUFACTURE
DO NOT POLLUTE THE ENVIRONMENT
WEEE SYMBOL (RECYCLE AS ELECTRONIC WASTE, DO NOT DISPOSE WITH
HOUSEHOLD WASTE)
RECYCLING SYMBOL
WARNING:
DO NOT SIT ON FOOTRESTS
SAFE WORKING LOAD OF FOOTRESTS
DO NOT PUT ANY OBJECTS ON UNDERCARRIAGE
JACK FOR ATTACHMENT OF CONDUCTOR FOR POTENTIAL EQUALISATION

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Fig. Location of warning labels

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1.6Product Label with UDI
The illustrations of the product labels below are for explanation of the symbols and elds on the product labels only.
1 Manufacturer address
2Serial number
3 Date of manufacture (Year-Month-Day)
4DI (Device Identier) GTIN (Global Trade Item Number)
5 PI (Product Identier)
62D Bar Code (GS1 DataMatrix) DI+PI=UDI
7 Electrical specications
8 1D Bar code GS1-128 (Serial number)
9Symbols
Fig. Product Label with UDI (Graciella)
1
98
7
3
46
2
5
Fig. Location of the product label (Graciella)

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1.7Audible alarm
SOUND MEANING
Sound 0,5 s, Interval 2,5 s Error detected in safety circuit of STOP function
Continuous signal CB ( Control Box) electronics overheated
Continuous signal Motor overloading
Short sound when positioning the seat Zero seat position reached
Short sound when positioning the seat If the seat reaches 12° when moving upwards

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1.8Denition
Basic Chair Conguration Model conguration
Chair weight The value depends on the product conguration, accessories or
customer adjustments.
Duty Cycle Cycle of operation of the motor: time of activity/time of rest.
Safe working load The highest allowable load on the chair (patient and accessories)

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1.9Abbreviations
AC ( ~ ) Alternating Current
CE European Conformity
dBA Sound Intensity Unit
DC ( = ) Direct Current
EMC Electromagnetic Compatibility
HPL High Pressure Laminate
HW Hardware
INT. Duty Cycle
IP Degree of protection
LED Light Emitting Diodes
ME Medical Electrical (Equipment)
REF Reference number (product type depending on the congura-
tion)
SP Serial number
SW Software
SWL Safe working load
UDI Unique device identication (for medical devices)
WEEE Waste Electrical and Electronic Equipment
SCU System Control Unit

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2Safety Instructions
WARNING!
Improper handling of the mains cable, eg. by twisting, cutting or other mechanical damage, is dangerous!
WARNING!
When routing the cables of other devices through the Graciella chair through parts of this medical chair, avoid
pinching these cables!
WARNING!
To reduce the risk of electric shock, this appliance must be connected to a mains supply with a protective
earth connection.
WARNING!
Modications to this device are prohibited.
WARNING!
Do not modify this device without authorization from the manufacturer.
WARNING!
If this device is modied, appropriate inspections and tests must be carried out to ensure the continued safe
use of the device.
WARNING!
No additional power strip or extension cord may be connected to the medical electrical system.
WARNING!
Any major accident involving the device should be reported to the manufacturer and to the competent authori-
ty of a member state in which the user and/or patient is competent.
WARNING!
Fuses and power supplies may only be replaced with tools by authorized and trained personnel!
WARNING!
This medical device is not intended for use in an oxygen-enriched atmosphere!
WARNING!
This medical device is not intended for use in the presence of ammable substances!
WARNING!
This medical device is not a portable electrical device!
WARNING!
Make sure that the mandatory cycle is observed during chair positioning (2 min ON / 18 min OFF)!

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WARNING!
The patient may only use the selected controls if the medical staff considers that the patient's physical and
mental condition corresponds to this and only if the medical staff has trained the patient in accordance with
the instructions for use!
WARNING!
During specic examinations and specic treatments, signicant risks of Interaction due to medical electrical
equipment may occur.
FIRMWARE
The chair contains rmware that may only be updated by an authorized service technician.
This rmware is protected against unauthorized access by a mechanical cover (access requires tools), a seal (compo-
nents with the processor are sealed), exclusive compatibility with an authorized software tool and checking the compati-
bility of the new rmware with the chair.
►Carefully follow instructions of the user manual.
►Use the chair exclusively if it is in perfect working order.
►If necessary, check the chair functions daily or at each shift change.
►Ensure any user has read and understood this manual completely before operating the product.
► Use the chair exclusively with the correct mains supply.
► Ensure that the chair is operated exclusively by qualied personnel.
► Move the chair exclusively on even, hard-surfaced oors.
► Replace any damaged parts immediately with original spare parts.
► Ensure that maintenance and installation are performed exclusively by qualied personnel who have been trained by the manu-
facturer.
► During peak loads or unavoidable excess loads place Mattress Platform in the lowest position.
► Take care to avoid injuries or squeezing when operating moving parts.
► When using a platform extension or infusion stands, ensure that nothing will be damaged when you move or adjust the chair.
► Ensure that the castors are locked prior to use.
► Never use the chair in areas where there is a hazard of explosion.
► Never handle the mains plug with wet hands.
► Disconnect the chair from the mains exclusively by pulling the mains plug.
► When pulling the mains plug, always hold the plug, not the cable.
► Position the mains cable so that there are no loops or kinks in the cable; protect the cable from mechanical wear and tear.
► Improper handling of mains cable can cause an electric shock hazard, other serious injuries.
► Ensure that the stipulated duty cycle of motor is not exceeded.
► To change fuses or cables contact service organisation authorized by manufacturer.
► Ensure that the moving parts of the chair are not blocked.
► To prevent failures, use exclusively the manufacturer’s original accessories.
► Ensure that the stipulated safe operating load is not exceeded.
► Do not modify chair and its components without the manufacturer´s approval.
► Do not exceed the maximum patient weight limit (see Mechanical Specications).
► Do not use the SCU near ammable gases. (This does not apply to oxygen cylinders.)
► Do not hang anything on any cable.
► Choose a suitable location to place chair accessories and other objects to prevent unintentional activation of buttons or controls,
which may result in readjustment of the chair.
► Do not use the chair if its parts (eg. parts of the platform) have been removed, except for those parts that are intended for re-
moval (eg. footrests).
► After each emergency situation always check if any of the controls of accessories (foot controls, hand controls) have not been
pressed accidentally.
► To avoid injury or crushing, take extra caution when operating any moving parts of the chair.
► To prevent unintentional activation of moving parts during any use of the chair, always check that no controls on the chair were
inadvertently pressed by persons or other objects.

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3Unpacking instructions
Before connecting the chair to the mains, read the Commissioning chapter carefully.
► Cut the securing tape on the box.
► Remove the top lid and ring of a box. Cut or step on the corners of the lower wall at the back of the chair so that the chair can be
conveniently removed from the pallet.

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► Gradually remove all accessories, including the power cord, from the tray. Discard empty containers.
► If a step is part of the chair, remove it.

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► Lift the base cover, cut 4x cable ties holding the chair to a pallet. Then the chair can be transferred from a pallet to the oor by
two people.
► Then remove all fixing and protective material from the chair

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Before connecting the chair to the mains, read the Commissioning chapter carefully.

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4Intended Use
4.1Intended use
Examination and treatment in gynaecology. The chair is used for gynaecological examination and ultrasound examination, respec-
tively for small outpatient operations. Basic functions include lying down, sitting and supporting the patient.
4.2User population
Women and girls of any age for a preventive examination or if they experience irregularities in the breasts, genitals, menstrual
cycles or if they become pregnant.
Nurses (doctor, nurses, technical staff, operating staff, cleaning staff)
4.3Contraindications
The medical device must not be used in any other way, for example as a patient transport chair, operating table or as a chair with
unapproved accessories.
The chair must not be used with patients exceeding the maximum weight specied in the user manual.

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5Product Description
5.1Chair with footrests - without vertical adjustment
4
3
12
Fig. Chair with footrests - without vertical adjustment
5
6
1. Base
2. Lifting columns
3. Seat section
4. Backrest
5. Footrest
6. Foot controller