Schmitz arco-matic 200 M User manual

Instructions for use
Examination and
treatment chair
arco-matic 200 M / 300 M
arco-matic 114.9600.0
arco-matic 114.9700.0

2Instructions for use arco-matic 200 M / 300 M -
V
ersion 2018-05-08 GBR ID no. 2038823A
Table of contents
These instructions for use ......................................................................................................................4
General.............................................................................................................................................................. 4
Warnings ........................................................................................................................................................... 4
Text symbols...................................................................................................................................................... 4
Important safety information .................................................................................................................. 5
Regulatory .............................................................................................................................................6
Product classification ........................................................................................................................................ 6
Intended use...................................................................................................................................................... 6
Approved accessories ....................................................................................................................................... 7
Device description..................................................................................................................................9
Diagram ............................................................................................................................................................. 9
Features.............................................................................................................................................................11
Control units.....................................................................................................................................................12
Delivery ................................................................................................................................................13
Storing the product ..........................................................................................................................................13
Transport to destination ...................................................................................................................................14
Unpacking.........................................................................................................................................................14
Transport at destination ...................................................................................................................................15
Setup ................................................................................................................................................................16
Preparation for operation.......................................................................................................................17
Levelling ........................................................................................................................................................... 17
Setting up a hardwired connection (optional) ..................................................................................................18
Fitting the back foot section cover ................................................................................................................. 20
Connecting the foot control unit..................................................................................................................... 23
Fitting the front foot section cover.................................................................................................................. 24
Connecting the hand control unit ................................................................................................................... 25
Connecting .......................................................................................................................................... 26
Mains connection ............................................................................................................................................ 26
Potential equalisation (optional, 101.0481.0).................................................................................................... 26
Sockets on the device (optional, 101.0482.0) ................................................................................................. 27
Positioning patients .............................................................................................................................. 29
Operation ............................................................................................................................................30
Safety information...........................................................................................................................................30
Switching on /
off ............................................................................................................................................. 31
Hand control unit ........................................................................................................................................... 32
Foot control unit ............................................................................................................................................. 37
Standard accessories............................................................................................................................ 39
Back pad ......................................................................................................................................................... 39
Seat pad ..........................................................................................................................................................40
Head pad ..........................................................................................................................................................41
Rinsing basin.................................................................................................................................................... 42
Cradle of the hand control unit ...................................................................................................................... 43
Side rail accessories .............................................................................................................................44
Arm rest (101.0019.0) ......................................................................................................................................44
Göpel leg support (101.0459.0), attachment clamp (101.1670.0) .................................................................. 45
Other optional accessories ................................................................................................................... 49
Foot supports (101.0492.0) ............................................................................................................................49
Protective cover for foot supports (101.0475.0) ..............................................................................................50
Göpel leg support (101.0493.0) .......................................................................................................................51
Head cushion (101.0472.0) .............................................................................................................................. 53
Mobility (101.0466.0) ...................................................................................................................................... 54
Foot rest for the doctor (right: 01.0468.0, left: 101.0469.0) ........................................................................... 56
Leg plate (101.0471.0) ..................................................................................................................................... 57
Paper roll (101.0489.0) .................................................................................................................................... 58
Rinsing basin with convenient holder (101.0495.0) ......................................................................................... 59
Colposcope support (101.0467.0) ...................................................................................................................60
Potential equalisation (101.0481.0) ...................................................................................................................61
Cleaning and disinfecting ..................................................................................................................... 62
Pads ................................................................................................................................................................. 63
Stainless steel parts.........................................................................................................................................64
Rinsing basin....................................................................................................................................................64

Instructions for use arco-matic 200 M / 300 M - Version 2018-05-08 GBR ID no. 2038823A 3
Replacing fuses .................................................................................................................................... 65
Technical Service ................................................................................................................................. 66
Wear parts....................................................................................................................................................... 67
Visual and functional checks........................................................................................................................... 67
Disposal...............................................................................................................................................69
Product identication........................................................................................................................... 70
Identication plate .......................................................................................................................................... 70
Symbols used ................................................................................................................................................... 71
Technical data...................................................................................................................................... 73
Connection dimensions ........................................................................................................................ 76
EMC declaration .................................................................................................................................. 77
EC Declaration of Conformity (including accessories) ............................................................................ 79
Glossary .............................................................................................................................................. 82
Index ...................................................................................................................................................84
Contact information ............................................................................................................................. 88

4 Instructions for use arco-matic 200 M / 300 M - Version 2018-05-08 GBR ID no. 2038823A
These instructions for use
General
These instructions for use reect the state of knowl-
edge at the time of printing and make no claim to
completeness. The information provided in these
instructions for use may be outdated due to the
ongoing technical development of our products.
However, all information is regularly updated in
revisions.
Illustrations in these instructions for use are not
necessarily to scale.
Keep these instructions for use at the place of use of
the product.
These instructions for use must be read and
observed by all persons who use, operate or clean
the product.
To be able to use the described product safely, the
provisions of these instructions for use must be
observed. Please observe in particular warnings,
ambient conditions, installation instructions, oper-
ating instructions, inspection and maintenance
regulations, as well as the standards listed in these
instructions for use.
Warnings
A risk assessment pursuant to ISO 14971:2007+
amendment:2009 (Risk management for medical
devices) was performed for this device. The signal
words, symbols and colours of the warnings were
selected in accordance with ANSI 535.6.
The warnings were scaled in accordance with the
following denitions for risk assessment.
DANGER!
“DANGER” refers to a hazardous situation which
could result in serious injury or death if it is not
avoided. Serious injuries are irreversible injuries
requiring permanent and regular medical care.
WARNING!
“WARNING” refers to a hazardous situation which
could result in moderate to serious injury if it is not
avoided. This includes reversible injuries requiring
care or examination by a medical professional.
CAUTION!
“CAUTION” refers to a hazardous situation which
could result in slight to moderate injury if it is
not avoided. This includes reversible injuries not
requiring medical care.
NOTE
“NOTE” refers to information not relating to personal
injury, e.g. information relating to damage to prop-
erty.
RECOMMENDATION
Recommendations are information that helps readers
use the product better, longer and more safely.
Text symbols
A triangle before the text means:
Execute this work step.
Execute this partial work step.
A square before the text means:
This is the result of the previous action.
A bullet point before the text means:
•This is part of an itemisation.

Instructions for use arco-matic 200 M / 300 M - Version 2018-05-08 GBR ID no. 2038823A 5
Important safety information
Use of the product
This product is state-of-the-art and was built
according to recognised safety rules. Nevertheless,
risks to the life and limb of users or third parties
may occur, or this product and other assets may be
adversely aected by the use of this product. This
product must only be used in sound condition and
for its intended use.
Suitability for use in oxygenated atmosphere
The examination chair must not be operated in an
oxygenated atmosphere.
Technical changes
It is not permitted to modify the examination and
treatment chair without the consent of the manufac-
turer.
Attaching accessories
When mounting accessories, always check the
condition of the accessory, and make sure that it is
attached securely.
Replacement parts
Replacement parts have to meet the requirements
established by SCHMITZ u. Söhne. Using original
replacement parts guarantees at all times that the
parts comply with requirements.
Non-slip setup
Before and during use of the product, it must be
ensured that the product has sucient oor adhe-
sion and that there is good slip resistance for both
product and user.
Mandatory training
This product may only be operated by persons
instructed in its proper use.
Patient positioning
The user must be familiar with and must comply with
the applicable organisational and national rules and
regulations for the proper positioning of patients.
The nursing sta are responsible for ensuring that
the patients are positioned in such a way that no
threats are posed to respiration, the nervous system
or the circulatory system. This applies in particular to
anaesthetised or unconscious patients.
HF devices
Combination with HF or debrillator devices is
possible. Please note that the patient must be insu-
lated from the examination and treatment chair. Use
electrically insulated underlays between the patient
and the examination and treatment chair. To this end,
the instructions for use issued by the device manu-
facturer must be complied with.
Checklist
Perform a visual and functional check regularly
according to the device-specic checklist provided
in these instructions for use.

6 Instructions for use arco-matic 200 M / 300 M - Version 2018-05-08 GBR ID no. 2038823A
Regulatory
Product classication
In combination with the accessories listed in “Tab.
1” on page 8, the product is a Class I medical
device according to Annex IX of the Medical Device
Directive 93/42/EEC. Harmonised standards were
used to assess compliance. The product meets the
fundamental requirements according to Annex I of
Directive 93/42/EEC, as well as of amending Council
Directive 2007/47/EC regarding medical devices
(Medical Device Directive).
Intended use
Only uses that are listed in this “Intended use”
chapter are intended for the purposes of IEC 60601-
1:2005 + amendment: 2006 + amendment: 2007 +
supplement1:2012.Any other use will result in an
exclusion of liability.
The examination and treatment chair arco-matic is
intended for use in human medicine only.
The examination and treatment chair may be used
for the following purposes:
•for the short-term positioning of patients for
urological examinations and treatment of
non-anaesthetised or sedated persons. A person
placed under the care of a guardian may only be
positioned on the examination chairs under super-
vision. Under these same conditions, the exami-
nation chair can also be used in gynaecology and
proctology.
The examination and treatment chair may not be
used:
•as an operating table,
•for transporting patients.
The safe working load of the examination and
treatment chair as per IEC 60601-1:2005 + amend-
ment:2006 + amendment:2007 + supplement 1:2012
is 250 kg less the weight of the attached accessories.
It may only be used in Group 0 and Group 1 medical
rooms according to and/or IEC 60364-7-710:2002-11.
Permissible user groups for the product are:
•Trained medical personnel (doctor/nurse)
•Trained cleaning sta
•Hospital technicians

Instructions for use arco-matic 200 M / 300 M -
V
ersion 2018-05-08 GBR ID no. 2038823A 7
Approved accessories
Accessories from SCHMITZ u. Söhne were devel-
oped for and tailored to this product (for a list of
accessories, see the table below). Third-party acces-
sories must be inspected and used with reference to
their instructions for use.
(*) The corresponding weight of the patient is indi-
cated in brackets.
Example: a safe working load of ‘‘60 (250) kg’’ means
that the accessory can support a weight of up to 60
kg. The part of the body that weighs 60 kg indicates
a total body weight of 250 kg.
Fig. 1
Notes regarding the following table (sample values)
Article no. Description Safe working load
as per IEC 60601-
1:2005, (*) in kg:
Net
weight
per unit in kg :
101.0492.0 Foot supports for positioning the patient’s legs. 25 4
101.0464.0 Side rails for seat section (pair), 150 mm long, used to
attach side rail accessories
101.0466.0 Integrated double castor (set) for the examination and
treatment chair (‘‘mobility’’). Serves to transport the
examination and treatment chair without a patient.
101.0472.0 Magnetic head cushion for positioning the patient’s
head.
101.0474.0 Leatherette cover (pair) to improve the grip on the
Göpel leg support
101.0475.0 Protective covers (pair), to protect the foot supports
when used with shoes.
101.0482.0 2 sockets as power supply for accessories attached to
the examination and treatment chair, such as colpo-
scopes or examination lights
25 0.3
250 5
/ 0.51
/ 0.2
/ 0.1
/ /
101.0487.0 LED illumination / /
101.0493.0 Göpel leg support with integrated handle, for posi-
tioning the patient’s legs during examination and treat-
ment.
25 6
101.0471.0 Extensible leg plate to position the patient’s legs 50 3
101.0467.0 Colposcope support (attachable on both sides) for
mounting colposcopes.
101.0473.0 Leatherette cover (pair) to improve the grip on the foot
support
101.0478.0 Foot supports, short (version), for positioning the
patient’s legs during examination and treatment
101.0481.0 Potential equalisation to reduce the patient leakage
current
101.0483.0 2 sockets for the Swiss market as power supply for
accessories attached to the examination and treatment
chair, such as colposcopes or examination lights
25 7
/ 0.2
25 4
/ /
/ /
101.0489.0 Paper roll, 500 mm wide, as hygienic cover for the pads. / 1.5
101.0019.0 Arm rest, serves to stabilise the patient’s arm 20 6.8
101.1670.0 Attachment clamp (piece) for mounting approved
accessories on the side rails.
25 0.7
101.0459.0 Göpel leg support for positioning the patient’s legs
during examination and treatment
see ‘‘Safe working 4
load’’ on page 45

8 Instructions for use arco-matic 200 M / 300 M - Version 2018-05-08 GBR ID no. 2038823A
Article no. Description Safe working load
as per IEC 60601-
1:2005, (*) in kg:
Net weight
per unit:
101.0463.0 Side rails for seat section (pair), 290mm long, for
mounting side rail accessories
25 0.6
101.0468.0 Foot rest for the doctor, to support the doctor’s feet
during the examination (right-sided version).
25 1.5
101.0469.0 Foot rest for the doctor, to support the doctor’s feet
during the examination (left-sided version).
25 1.5
101.0476.0 Protective cover for seat pad to protect the seat pad / 0.2
101.0465.0 Side rails for the back section for mounting accessories
on the back section
20 1
Tab. 1
Approved accessories from SCHMITZ u. Söhne GmbH & Co. KG

Instructions for use arco-matic 200 M / 300 M - Version 2018-05-08 GBR ID no. 2038823A 9
Device description
Diagram
Fig. 2
Examination and treatment chair arco-matic 200 M / 300 M
Head pad Head cushion (optional,
101.0472.0) Back pad
Leatherette cladding Seat pad Lifting arm
Rear foot section cladding F o o t s u p p o r t s Rinsing basin
Foot control unit (e.g. arco
200 M) Hand control unit Front foot section cladding
Tab. 2
Position numbers of the above illustration

10 Instructions for use arco-matic 200 M / 300 M - Version 2018-05-08 GBR ID no. 2038823A
Fig. 3
Examination and treatment chair arco-matic 200 M / 300 M (back)
Locking pedal (optional) On/o switch Fine-wire fuses of the inte-
grated sockets
Attachment screws for the
rear foot section cladding
Screw thread for the attach-
ment screws Cable brackets
Integrated socket (optional,
101.0482.0) Mains connection Potential equalisation (optional, 101.0481.0)
Tab. 3
Position numbers of the above illustration