Digiterm COMFORT-4 ECO User Manual
Digiterm COMFORT-4 ECO is a therapy chair designed for patient medical treatment, such as hemodialysis, chemotherapy, and pre and post-surgical care. With its adjustable segments, it provides a comfortable position for patients of different ages and weights. The chair's motors can be controlled using a handset, allowing for simultaneous adjustment of multiple segments.
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COMFORT-4 ECO
Therapy chair
User Manual
V6.1 EN
U.S. Distribution Partner for:
COMFORT-4 ECO
Contents
1. Symbols used in the User Manual and on the chair ................................................ 2
2. Function of the chair ................................................................................................... 3
3. Putting in operation .................................................................................................... 4
4. Operating the chair ..................................................................................................... 8
4.1. Armrest adjustment ............................................................................................................. 8
4.2. Use of the handset .............................................................................................................. 8
4.3. Setting the footrest manually ............................................................................................... 11
4.4. Setting the motorised footrest (*) ......................................................................................... 11
4.5 Comfort-T2 multifunctional table (*) ...................................................................................... 11
4.6 Infusion bottle holder (*) ....................................................................................................... 11
4.7 Reading lamp (*) .................................................................................................................. 11
4.8 Transparent protecting plastic cover for legrest and footrest (*) ........................................... 12
4.9 Paper roll holder (*) .............................................................................................................. 12
4.10 Washable net bag (*) ......................................................................................................... 12
4.11 Stainless steel armrest protection (*) .................................................................................. 13
4.12 Central brake (*) ................................................................................................................. 13
4.13 Battery unit (*) .................................................................................................................... 13
5. Safe operation of the chair ......................................................................................... 14
6. Disinfections and cleaning ......................................................................................... 16
7. Maintenance and troubleshooting ............................................................................. 17
7.1. Routine maintenance .......................................................................................................... 17
7.2. Checking the electronic control ........................................................................................... 17
8. Technical data ............................................................................................................. 18
8.1. Transport and storage conditions ........................................................................................ 19
8.2. Operating conditions ........................................................................................................... 19
8.3 EMC requirements ............................................................................................................... 19
8.4. Standards applied ............................................................................................................... 21
8.5. Recycling of used parts and special waste disposal ............................................................ 21
9. Periodic technical safety inspection
9.1 Check List for inspection
9.2 Protective earth conductor resistance measurement
10. Spare parts list order form
11. Spare parts list
(*) depending on construction
Version 6.1 EN 1 01.04.2016.
COMFORT-4 ECO
The characteristics and operation of the chair have to be known in order to benefit from its advantages. Therefore please read the User Manual , particularly the sections entitled Putting in operation and Safe operation of the chair before use.
1. Symbols used in the operating instructions and on the chair
This symbol marks information, which is relevant for the safety and must be observed.
Maximum patient weight
Safe working load
For inside use only.
Degree of protection against electric shock type B applied part
Equipotential connector
Measuring earth point
Protecting network
Emergency STOP (*)
Version 6.1 EN 2 01.04.2016.
COMFORT-4 ECO
Please do not sit to the legrest!
Do not drive onto the mains cable!
Do not drive onto the handset cable!
Do not touch it!
(*) depending on construction
2. Function of the chair
The chair has been designed and constructed primarily for patient medical treatment, for example hemodialysis, chemotherapy, pre and post-surgical, etc..
With the help of the handset the segments of the therapy chair can be adjusted to any desired position that makes treatment comfortable for the patient.
Patient population:
Age: from child to old age
Weight: up to 200 kg or 440 lbs.
Patient state: alert and aware
Version 6.1 EN 3 01.04.2016.
COMFORT-4 ECO
3. Putting in operation
● Before commissioning the chair, remove the packaging and protective plastic wrap.
● The type of chair (and options) is marked on the packaging and the list of accessories is included in the documentation.
Note! Please check that the chair accessories (remote control handset, armrest strap and headrest pillow) are present and complete.
•
The motor actuating rod of the legrest is to be connected to the legrest frame using the pin supplied, according to the illustration. Secure the pin using the washer and fixing ring. (Figure 1) fixing ring pin washer
Figure 1
● Check whether the handset connection plug is appropriately inserted into proper connector of electronic control unit (Figure 6/a; 6/b) found under the seat.
● Check the local mains voltage against the value indicated on the data plate of the chair before use.
If the voltage matches insert the electrical plug into a mains outlet.
Before switching the chair on, it should be checked whether condensation (possible with a temperature change) is present on any electrical components. If there is condensation, then the chair has to be allowed to reach room temperature.
The control box does not work without closing plug, that should be connected tightly into this socket (Figure 6/a; 6/b)
Version 6.1 EN 4 01.04.2016.
COMFORT-4 ECO
Attaching the upholstery:
Using the handset, adjust the chair in such a way that the legrest is in line with the seat plate and the backrest is vertical (Figure 2). This is the easiest position in which to attach the upholstery.
There are two straps on the back of the upholstery. These have to be pulled onto the frame (Figure 3, Figure 4).
Figure 2
Figure 4
Figure 3
With the velcro straps found on the two sides of the sitting part of the upholstery, secure the upholstery to the frame (Figure 5).
Figure 5
Version 6.1 EN 5 01.04.2016.
COMFORT-4 ECO
Attach the headrest pillow to the backrest with the velcro straps. Secure the armrest strap included in the accessories to the armrest. The armrest strap is used to position the remote control handset.
● Check whether the motors work properly with the help of the handset.
● Position the chair such that sufficient space is available to enable unhindered adjustment of the chair in any position and access from all sides.
Check whether the power or the handset cable is not stretched or ends up under the wheels or another object while operating the chair.
Closing plug
Handset connector
Motor connectors
(In case of less Motors are connected end cap must be connected)
Reading lamp connector (*)
Battery unit connector (*)
(In case of no Battery unit end cap must be connected)
Power cable
Figure 6/a
Control box without options
(Basic version)
(*) depending on construction
Version 6.1 EN 6 01.04.2016.
COMFORT-4 ECO
Connection cable between the main and slave control unit
Motor connector s
Slave control box (*)
Battery unit (*)
Power supply connection cable
(24V DC)
(*) depending on construction
Handset connector (*)
(in case of 5 motors)
OR
Connection cable between the slave control unit and junction box (*)
End cap
Closing plug
OR
Emergency Stop
Switch connector
Connection cable between the main and slave control unit (*)
OR
Connection cable between the main control unit and junction box (*)
Junction box (*)
Motor connectors
(In case of less Motors are connected end cap must be connected)
Handset connector
(in case of optional
Trendelenburg footswitch)
Reading lamp connector (*)
Main control box
Motor connector (*)
OR
Power supply for slave control box (*)
Power cable
Power cable junction box (*)
(except EU and
GB power cable)
Battery unit connector (*)
(In case of no
Battery unit end cap must be connected)
Figure 6/b
Control box with options
Version 6.1 EN 7 01.04.2016.
COMFORT-4 ECO
4. Operating the chair
4.1 Armrest adjustment
The height of the armrest can be adjusted by pulling the indexing plunger on the telescoping rail, moving the armrest up or down and then pushing it back again.
By loosening the knurled knob directly under the armrest, the armrest can be cantilevered and slipped up and down along its longitudinal axis. The distance between the armrests can be adjusted by rotating the armrest.
The enhanced mobility of the armrests makes it possible to comfortably seat differently sized patients. Folding the armrest up to the backrest facilitates entering the chair from the side. (Figure 7)
Figure 7 Telescopic armrest
4.2 Use of the handset
The adjustment of the chair is done by using the handset (Figure 8/a; 8/b). The chair moves only as long as a button of the handset is depressed. The control of the chair makes it possible that more than one motor is active at any time.
Depressing any button is signalled by a green LED on the handset.
More than two minutes of uninterrupted pressing of the button should be avoided!
The chair can be set into the Trendelenburg position from any position within a very short space of time by pressing the red button on the handset.
Version 6.1 EN 8 01.04.2016.
COMFORT-4 ECO
Remote control handset
ENTRY/LEAVE
ENTRY / LEAVE position
Backrest down
Seat tilt down
Legrest down
Seat height down
Version 6.1 EN
LED indicates button pressing
Figure 8/a
9
BED position
TRB
Backrest up
Seat tilt up
Legrest up
Seat height up
Head-down position
01.04.2016.
COMFORT-4 ECO
Remote control handset (*)
(if the chair is equipped with motorised footrest adjustment and Battery option)
Backrest down
Seat tilt down
Legrest down
Seat height down
Footrest down
ENTRY/LEAVE
ENTRY / LEAVE position
LED indicates button pressing
BED position
TRB
Backrest up
Seat tilt up
Legrest up
Seat height up
Footrest up
LED indicates battery charging (*)
OR
Power on (*)
Figure 8/b
(*) depending on construction
Head-down position
Version 6.1 EN 10 01.04.2016.
COMFORT-4 ECO
4.3 Setting the footrest manually (*)
The position of the footrest can be modified in length. The footrest should be held to prevent it from slipping, then by loosening the knurled knob on the left side the footrest can be adjusted into the desired position and secured by tightening the knurled knob.
4.4 Setting the motorized footrest (*)
With handset, can be adjusted by keeping pressed the button marked according to desired direction (Figure 8/b).
4.5 Comfort-T2 Multifunctional table (*)
It can be mounted on either sides of the therapy chair (Figure 9).
4.6 Infusion bottle holder (*)
It can be installed onto either sides of therapy chair and the height of bottle holder is adjustable (Figure 10).
Figure 9
Comfort-T2 Multifunctional table
4.7 Reading lamp (*)
Figure 10
Infusion bottle holder
The lamp can be switched on and off and dim the light by touch switch on head of the light. Functions: - quick touch by finger: switch on or off the light (Figure 11a).
- long touch by finger: dim or bright the light (Figure 11b).
.
4
8
Figure 11a Figure 11b
Attention: support is not allowed to be rotated fully around because cables might be damaged!
Version 6.1 EN 11 01.04.2016.
COMFORT-4 ECO
4.8 Transparent protecting plastic cover for legrest and footrest (*)
The plastic cover is attached by velcro straps onto upholstered legrest and footrest. Removable for easy disinfection and cleaning. (Figure 12;13)
Figure 12
Figure 13
Transparent protecting plastic cover for the footrest
Transparent protecting plastic cover for the legrest
4.9 Paper roll holder (*)
The paper roll holder holds and dispenses paper that helps protect upholstery against dirt, blood and fluids. etc.
Note: The washable net bag and the paper roll holder can not be mounted on the chair together!
(Figure 14)
4.10 Washable net bag (*)
Washable net bag for storing Patient’s belongings.
The washable net bag can be fixed with velcro straps to the back of the chair, in order to store mainly small, lighter, personal things. (Figure 15)
Note: The washable net bag and the paper roll holder can not be mounted on the chair together!
Figure 14
Paper roll holder
Figure 15
Washable net bag
Version 6.1 EN 12 01.04.2016.
COMFORT-4 ECO
4.11 Stainless steel armrest protection (*)
To protect the upholstered armrest against damage.
Note: Fits for TILT UP ARMREST WITH HEIGHT AND
LONGITUDINAL ADJUSTMENT only. (Figure 16)
Figure 16
Stainless steel armrest protection
4.12 Central brake (*)
The central brake can be simply
locked to fix the chair.
Figure 17
Central brake
4.13 Battery unit (*)
The chair is equipped with a Battery unit to ensure the operation of chair during power failure assuring the patient’s comfort. In this case
the handset operates,
the Trendelenburg foot-switches(*) on the bottom frame operate further on from battery,
The battery charge is indicated by CHARGE LED on the handset (Figure 8/b).
If the yellow CHARGE LED on the handset is lighting continuously the battery unit is charged. If the yellow CHARGE LED is flashing the battery unit is charging.
Note! If chair is not equipped with optional battery unit the yellow
CHARGE LED will light continuously in order to indicate power on.
In case of power failure use the electronic adjustments only for Emergency or exiting the chair in order to save battery capacity.
(*) depending on construction
Version 6.1 EN 13 01.04.2016.
COMFORT-4 ECO
Note! In case of battery back-up operation depressing any button of the handset is signaled by a short sound!
After 2 minutes of continuous battery operation the battery should be charged. Do not connect the battery onto external charge device.
5. Safe operation of the chair
Always check whether the power and the handset cable are intact before switching the unit on.
If the chair is equipped with EMERGENCY-STOP switch(*):
In case of emergency press the EMERGENCY-STOP switch,
(signed by red label, see Figure 18) to prevent the chair’s unintended movement and stop the operation of the handset.
Attention! There is electrical shock hazard due to the
EMERGENCY-STOP button could not provide disjunction of the chair from the main voltage!
After stopping the reason of the emergency, the chair can be put into action by turning off the EMERGENCY-STOP switch in the direction of the arrows which can be seen on the red head.
Attention! Do not use the EMERGENCY-STOP button for switching off the main voltage, because there is electrical shock hazard due to the EMERGENCY-STOP button could not provide disjunction of the chair from the main voltage!
(*) depending on construction
If the chair is NOT equipped with EMERGENCY-STOP switch(*):
In case of emergency, disconnect the chair’s power plug and the battery plug(*) from control unit in order to shut off the chair. The power plug and battery plug(*) must always be accessible during operations so that it is possible to shut down the chair at any time.
Figure 18
EMERGENCY-STOP switch (*)
Version 6.1 EN 14 01.04.2016.
COMFORT-4 ECO
For a long working life and in order to guarantee user safety, we recommend that the following points be observed:
● Position the chair in such a way that it is accessible from all sides and does not touch walls or other equipment objects when fully extended.
Not keeping safety distances around the chair during backrest adjustment could result in the chair backrest being driven into the wall behind the chair, this may cause additional dynamic overload on the backrest of the chair and lead to pivot bolt damage.
The below picture makes the installation instructions evident:
Figure 9 Expected safe operational environment
Please keep the prescribed safety distances around the chair in order to avoid any damages of the frame!
The Manufacturer shall not take responsibility for any consequences of misplacement and abnormal use.
● Check whether the brakes are applied on the casters or the central brake(*). The brakes should always be locked unless the chair is being relocated . Otherwise, there is a risk of accidents.
● The therapy chair should always be entered from the side with the armrest folded up. Make sure the armrest is not overloaded or damage may result.
● The chair should not be entered or exited over the legrest, because stepping on the footrest or the legrest can cause the chair to tip over or injury or damage may result.
● Do not sit onto the backrest when it is folded back, because the chair can tip over.
● Prevent the power cable from being damaged, because a damaged cable can cause fire or electric shock:
the power cable should not end up under the therapy chair wheels or another heavy object,
Version 6.1 EN 15 01.04.2016.
COMFORT-4 ECO
don’t leave the power cable near a source of heat, for example a heater,
when pulling it out of the outlet hold the plug not the cable.
Do not open the cover of the control box, because the ingress protection (IP) can not be set up again and voids the warranty!
A technical safety examination, as described in the attached check list in Chapter 9, should be performed after every repair, and on a two year basis. Please find the yellow label on the chair’s frame to see the date of next safety inspection. Copy the check list and fill it out!
6. Disinfection and cleaning
6.1 Disinfection
The materials used for the chair (plastics, artificial leather and colours) are resistant to the disinfectant products in common use in hospitals. The below matrix shows which disinfectants are recommended, conditionally recommended or not recommended for disinfecting upholstery (a solution of up to10% bleach and water may be used)
-
Recommended disinfectants.
-
Conditionally recommended disinfectants. Disinfectants should be tested beforehand on a hidden section of the material. If possible, use diluted and do not allow them to act for a prolonged period.
-
Not recommended disinfectants.
Version 6.1 EN 16 01.04.2016.
COMFORT-4 ECO
6.2 Cleaning
First clean on a daily basis the upholstery with warm water and mild soap using damp cloth. Regular and meticulous cleaning of the upholstery with water in addition to a mild soap can prevent hardening and embrittlement of the upholstered parts from such a materials like detergent, sweat, skin oils, hair spray, hand creams and similar things may affect the leather during treatment.
Avoid ingress of liquid or disinfectant into the electronic control box, motors and remote control handset. Cleaning of the mechanical parts
(motor actuating rods, bolts and joints) should only be done with a damp cloth. Abrasive cleaners should not be used and power washing should not be done.
7. Maintenance and troubleshooting
7.1 Routine maintenance
The following inspections and maintenance work should be done in every two years with the Technical Safety Inspection (find the check list in chapter 9):
● The hinges and joints of the legrest, backrest and armrest should be inspected.
● The knurled knob of the armrest should be inspected.
● The wheels should be checked to see whether they are securely fastened to the frame.
● The slip surface of the footrest should be thinly greased.
● If the knurled knobs or the mechanical parts of the armrests are damaged, they should be repaired immediately or exchanged.
● Check upholstery for damage.
7.2 Checking the electronic control
Damaged keypad membranes on the handset are to be replaced immediately to avoid further damage (short circuits caused by liquids entering the handset).
If the chair is connected to the mains but it cannot be operated by use of handset, then check whether the mains voltage is appropriate.
If the mains voltage is appropriate but operation cannot be realized by keeping pressed any button please change the handset.
If moving is still not working change the control unit.
If any motor cannot be operated, exchange the defective motor’s plug with a working one by unplugging wrong motor’s plug from its original socket and connect it to the neighbouring socket that operates properly with its own motor.
If this motor works in this socket it means there is no trouble with the motor.
Then please check electronic control unit and handset.
Version 6.1 EN 17 01.04.2016.
COMFORT-4 ECO
If you change a fuse or do checking or repairing inside the electronic control box, the mains plug must be disconnected from the wall-socket and pull the plug of battery back-up unit out of the control box which provides total isolation of the chair from the main voltage.
8. Technical data
Safe working load:
Maximum patient weight:
Horizontal surface length:
Chair surface width:
Seat height (to top of frame):
225 kg (495 lbs)
200 kg (440 lbs)
210 cm (82.5”)
60 cm
(23.5”)
47 - 70 cm (18.5
” – 27.5”)
Distance between telescopic armrests(*): 48 - 60 cm (19” – 23.5”)
Distance between ball-jointed armrests(*): 54 cm (
21.25”)
Frame colour:
Upholstery colour: white (RAL9001) light grey or any selected colour
Weight: 80 kg (175 lbs)
Angular range of the backrest:
Angular range of the seat:
Angular range of the legrest:
Footrest adjustment range:
80 0
35 0
30 0
29 cm (11.
5”)
Mains voltage:
Peak electric current admittance:
100V-240V, 50/60 Hz max. 4A
Protection class against electric shock: class I
Degree of protection against electric shock: Type B
Degree of protection against water ingress: Protected against splashing water
/IPX6/
Usage protection class: Not to be used in the presence of
Operation mode: flammable anaesthetic gas-air, anaesthetic gas-oxygen or anaesthetic gas-nitrous oxide continuous operation in addition to periodic loads
After a maximum of two minutes of continuous operation of the motors, an 18-minute pause must be observed.
Fuses used in the apparatus:
Circuit board
Reading lamp (LED)
1xT2.5A/250V
1xT6.3A/250V
1xT2.5A/250V
Version 6.1 EN 18 01.04.2016.
COMFORT-4 ECO
8.1 Transport and storage conditions
Temperature range:
Relative humidity:
10 … + 50 0 C (14° - 122°) max. 80 %
The equipment and its packaging has to be protected from moisture. The top of the factory cardboard packaging may not be loaded.
The equipment packaged on the wooden rack in the cardboard box may not be tilted from the horizontal position, which is marked on the box, while storing or moving it.
8.2 Operating conditions
Temperature:
Relative humidity:
(*) depending on construction
8.3 EMC requirements
+10 … + 40 max. 80 %
0 C (50° - 104°)
Installation and operation of the Comfort-4 Eco should be in accordance with the
EMC requirements of tables 1-4.
Table 1
Guidance and manufacturer’s declaration – electromagnetic emissions
The Comfort-4 Eco is intended for use in the electromagnetic environment specified below. The customer or the user of the Comfort-4 Eco should assure that it is used in such an environment.
Emission test Compliance
RF emissions CISPR 11
RF emissions CISPR 11 Class B
Harmonic emissions IEC 61000-3-2 Class D
Voltage fluctuations / flicker emissions IEC 61000-3-3
Applicable
Table 2
Group 1
Electromagnetic environment - guidance
The Comfort-4 Eco uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interface in nearby electronic equipment.
The Comfort-4 Eco is suitable for in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Guidance and manufacturer’s declaration – electromagnetic emissions
The Comfort-4 Eco is intended for use in the electromagnetic environment specified below. The customer or the user of the Comfort-4 Eco should assure that it is used in such an environment.
Immunity test
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient
/ burst IEC 61000-4-4
IEC 60601-1 test level
± 6 kV contact
± 8 kV air
± 2 kV for power supply lines
± 1 kV for input/output lines
Compliance level
± 6 kV contact
± 8 kV air
± 2 kV for power supply lines
± 1 kV for input/output
Electromagnetic environment - guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic materials, the relative humidity should be at least 30 %.
Mains power quality should be that of a typical commercial or hospital environment. lines
Version 6.1 EN 19 01.04.2016.
COMFORT-4 ECO
Surge IEC 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
± 1 kV differential mode
± 2 kV common mode
< 5 % UT
(>95 % dip in UT) for 0,5 cycle
40 % UT
(60 % dip in UT) for 5 cycles
70 % UT
(30 % dip in UT) for 25 cycles
< 5 % UT
(>95 % dip in UT) for 5 sec
Power frequency
(50/60 Hz) magnetic fields
IEC 61000-4-8
1 A/m 1 A/m
NOTE: U
T
is the AC mains voltage prior to application of the test level.
± 1 kV differential mode
± 2 kV common mode
< 5 % UT
(>95 % dip in UT) for 0,5 cycle
40 % UT
(60 % dip in UT) for 5 cycles
70 % UT
(30 % dip in UT) for 25 cycles
< 5 % UT
(>95 % dip in UT) for 5 sec
Table 3
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment. If the user of the
Comfort-4 Eco requires continued operation during power mains interruptions, it is recommended that the Comfort-4 Eco be powered from an uninterruptible power supply or battery.
Power frequency magnetic fields should be at levels characteristic of the typical location in a typical commercial or hospital environment.
Guidance and manufacturer’s declaration – electromagnetic emissions
The Comfort-4 Eco is intended for use in the electromagnetic environment specified below. The customer or the user of the Comfort-4 Eco should assure that it is used in such an environment.
Immunity test
IEC 60601-1 test level
Compliance level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V eff
150 kHz – 80 MHz
10 V/m
80 MHz
– 2,5 GHz
3 V
10 V/m
Portable and mobile RF communications equipment should be used no closer to any part of the Comfort-4 Eco, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended Separation distance: d = 1,2 √P d = 1,2 √P 80 MHz – 800MHz d = 2,3 √P 800 MHz – 2,5 GHz
Where the P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
Field strength from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.
Interference may occur in the vicinity of the equipment marked with the symbol.
NOTE 1: at 80 MHz and 800 MHz the separation distance for the higher frequency range applies
NOTE 2: This guideline may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and peoples. a
Field strength from fixed transmitters, such as base stations for radio (Cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Comfort-4 Eco is used exceeds the applicable RF compliance level above, the Comfort-4 Eco should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Comfort-4 Eco. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Version 6.1 EN 20 01.04.2016.
COMFORT-4 ECO
Table 4
Recommended separation distances between portable and mobile RF communications equipment and the Comfort-4 Eco
The Comfort-4 Eco is intended for use in an electromagnetic environment in which the radiated RF disturbances are controlled. The customer or the user of Comfort-4 Eco can help prevent electromagnetic interference by maintaining a minimal distance between portable and mobile RF communications equipment (transmitters) and the Comfort-4 Eco as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter P
[W]
Separation distance according to the frequency of transmitter [m]
150 kHz – 80 MHz d = 1,2 √P
80 kHz – 800 MHz d = 1,2 √P
800 kHz – 2,5 GHz d = 2,3 √P
0,01
0,1
1
10
0,12
0,38
1,2
3,8
0,035
0,11
0,35
1,1
0,07
0,22
2,7
2,21
100 12 3,5 7
For transmitter rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: at 80 MHz and 800 MHz the separation distance for the higher frequency range applies.
NOTE 2: This guideline may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and peoples.
8.4 Standards applied
EN 980:2008 (EN ISO 15223-1:2012)
EN 1041:2008
EN ISO 10993-1:2009+AC:2010
EN ISO 10993-5:2009
EN ISO 14971:2012
EN 60601-1:2006+AC:2010
EN 60601-1-2:2007+AC:2010
EN 60601-1-6:2007
EN 60601-2-52:2010
EN 62366:2008
EN 50581:2012
Quality and Environmental
Management System:
EN ISO 9001:2008
EN ISO 13485:2012+AC:2012
ISO 14001:2004
The COMFORT-4 ECO therapy chair complies with the requirements of Decree
93/42/EEC for medical devices.
8.5 Recycling of used parts and special waste disposal
When the equipment is first commissioned, when it is taken out of service and during the exchange of replacement parts, the following points should be considered:
● The packaging is not special waste and should be recycled.
● In the event of any questions about the disposal of parts and compliance with legal requirements, please obtain information from your local disposal company.
We hope that our product will contribute to your patient’s well-being, relaxation and comfort during treatment.
Version 6.1 EN 21 01.04.2016.
COMFORT-4 ECO
We welcome your suggestions. Please inform Champion Customer Service
(800-998-5018) if you have any special wishes or questions concerning our product. Our staff will be glad to advise you and provide further assistance.
We hope that you enjoy using your chair and thank you for placing your confidence in us.
Version 6.1 EN 22 01.04.2016.
9 . P e r i o d i c a l T e c h n i c a l S a f e t y I n s p e c t i o n
A TECHNICAL SAFETY INSPECTION , as described in the following check list, should be performed after placing the unit into operation, after every repair, and on two years basis. The instructions in the Operating Instructions and the Service Manual have to be followed and technical modifications have to be taken into account.
9.1 Check List for inspection
For the machine: Serial No.: ........................................ Type: COMFORT-4 Eco
Year of Purchase: ............................. User:……………………………
Electric schock protection : Class I.
Manufacturer:
Visual Inspection
Digiterm Ltd., H-3200 Gyöngyös, Ipar út 7.
1.
OK NOK
1.1.
1.2.
1.3.
1.4.
2.
2.1.
2.2.
2.3.
2.4.
2.5.
Checking the handset.
Press a button, and see whether the LED on the handset case lights up during pressing the button.
Checking backrest movement.
Check whether the backrest freely moves between its end positions when the Backrest buttons
are pressed.
Checking seat movement.
Check whether the seat freely moves between its end positions when the Seat buttons are pressed.
Checking legrest movement.
Check whether the legrest freely moves between its end positions when the Legrest buttons are
pressed.
Checking height adjustment movement.
Check whether the height adjustment freely moves between its end positions when the
Height adjustment buttons are pressed.
2.6.
2.7.
Checking combined movement.
Check whether the upholstered sections of the therapy chair freely move between their end positions when the Yellow and Red buttons are pressed on the handset.
Checking the movement into the Trendelenburg position.
Check whether the Trendelenburg position can be reached when the
Trendelenburg button is pressed on the handset or the Trendelenburg foot-switch (*) is pressed by foot on the underframe.
Check the two Trendelenburg buttons.
Checking electric footrest adjustment.(*) After selecting the footrest, check whether by pushing the UP/DOWN buttons, the 2.8. footrest freely moves between its end positions.
Checking the footrest mechanical settings.(*) After placing the legrest into a horizontal position, make sure that after loosening
2.9.
the securing screw it can be moved freely throughout its travel path and can be secured into any position.
Checking armrest movement.
Check whether the armrest can be fastened into various positions.
2.10.
Checking brake function of the castors. Check whether the brake function can be operated properly.
2.11. Checking the operation of the EMERGENCY-STOP switch (*).
Press the EMERGENCY-STOP switch and see whether the operation of the chair stops. Turn off the EMERGENCY-STOP switch
in the direction of the arrows, then repeat twice the above checking. The emergency-stop has to operate in each time.
3.
Function inspection of battery back-up operation in case of power failure(*)
3.1.
3.2.
Checking the power failure sound.
After removing the power plug from the mains a short warning sound will inform us about the battery operation.
Checking the operation of the Trendelenburg button in case of power failure. Check whether the therapy chair can be adjusted into Trendelenburg position when the Trendelenburg button is pressed on the handset and when the Trendelenburg
foot-switch (*) is pressed by foot on the underframe.
3.3.
Checking the intactness of the Mains cable.
Checking the intactness of the main and slave(*) control box.
Checking the intactness of the handset cable and membrane (handset foil).
Checking the attachment of the motors (the intactness of the fixing ring on the pin).
Function Inspection
4.
4.1
4.2.
4.3.
4.4.
Checking of the battery. Check whether the continuous operation during 2 minutes can be realized after a 3 hours long charging
(without movement), in battery back-up operation (mains plug disconnected) with loading (sitting in the chair), when the Yellow
buttons are pressed.
Electrical Safety Inspection according to EN 60601-1:2006
Protective earth conductor resistance measurement
(see details of measuring procedure in chapter 9.2)
(Measure it when the chair is equipped with EPN * see details in chapter 9.2
1.
2.
3.
4.
5.*
Measured value (**)
......................
.....[Ω]
...........................[Ω]
...........................[Ω]
...........................[Ω]
.................
..........[Ω]
Limit value
0.2 Ω
0.2 Ω
0.2 Ω
0.2 Ω
0.2 Ω
Earth leakage current measurement ( see details of measuring procedure in chapter 9.3)
Patient leakage current measurement ( see details of measuring procedure in
chapter 9.4)
Touch current measurement ( see details of measuring procedure in chapter 9.5)
1.
2.
3.
4.
........................[mA]
........................[mA]
........................[mA]
........................[mA]
1. ........................[mA]
2. …….................[mA]
3. ........................[mA]
4. ........................[mA]
1. ........................[mA]
2. ........................[mA]
0.5 mA
0.5 mA
1 mA
1 mA
0.1 mA
0.1 mA
0.5 mA
0.5 mA
0.5 mA
0.5 mA
(*) depending on options
(**) Please evaluate Measured values (whether they are OK or NOK) using Supporting material for inspection in chapter 9.2
RESULTS:
OK NOK
OK NOK
OK NOK
Therapy chair is to be operated normally:
Faults were found which could endanger patients, users or others:
YES NO
...............................................................................................................................................
Spare parts / supplementary items used:
Work required:
Date of next technical safety inspection:
...............................................................................................................................................
NO maintenance other: ..............................................................................................
The technical safety inspection was carried out by: Date: ................................................. Signature: .............................................................
9 . 2 P r o t e c t i v e e a r t h c o n d u c t o r r e s i s t a n c e m e a s u r e m e n t
Process:
Step 1.
Set the current load up to minimum 12A
Step 2.
Measure the earth conductor resistance between the measuring earth points on the chair (use relevant method is shown in the below photos and tables)
Length of measuring time: 5-10s
Step 3.
Check the measured values to the limit (see below the tables)
Measuring points on the chair frame: measuring earth point protecting network connections
1
6
8
2
3
4
5
5 EPN optional
1
2
3
6
4
A
B
Support for measuring methods:
Measuring
Steps
3.
4.
Measuring points
6 3
6 4
Expected resistance
(Limit value)
1.
2.
A B
6
6
1
2
5.* 6 5
(Measure it when the chair is equipped with EPN)
*
0.
2 Ω
0.
2 Ω
0.
2 Ω
0.
2 Ω
0.
2 Ω
10. Spare Parts List Order Form
Champion Manufacturing
Pieces
Customer Name:_________________________________________
Customer Address:________________________________________
Tel:_________________ Fax:__________________
Ordering spare parts for chair with serial number:_____________
COMFORT-4 ECO Therapy Chair (Art.-Nr. 7130368E)
Art.-Nr. Description
ECO - 34545119 Central operating brake diam.: 10cm twin wheel castors
ECO - 34545167 Detachable upholstery
– 11 cm
ECO - 34545099 Upper upholstery
ECO - 34545100 Lower upholstery
ECO - 34545101 Headrest pillow
ECO - 34540300 Armrest strap for handset
ECO - 34545166 Upholstered footrest for 11 cm foam
ECO - 34545080 Handset
ECO -34545081 Foil of the handset
ECO -34545406 Electronic box without reading lamp connector
ECO -34545407 Electronic box with reading lamp connector
ECO -34545329 Slave control box
ECO -34545216 Battery unit
ECO -34545008 Backrest motor
ECO -34545141 Seat tilt motor
ECO -34545381 Legrest motor
ECO -34545137 Seat height motor
ECO -34545192 Footrest motor
ECO -34545239 Upholstered armrest with edge protection (with longitudinal adjustment)
ECO -34545212 Armrest mechanism for tilt-up version
ECO -34545220 Armrest mechanism for tilt-up armrest right
ECO -34545221 Armrest mechanism for tilt-up armrest left
ECO -34545213 Armrest height adjusting stirrup
ECO -34545422 Power cable (US)
ECO -34545416 Reading lamp (LED)
Date:____________________ Signature:________________________
11. Spare Parts List
Figure Art.-No.
Electronic parts
ECO
34545080
Description
Handset
Figure Art.-No. Description
ECO
34545081
Foil of the handset
ECO
34545406
Electronic control box without reading lamp connector
ECO
34545362
Battery unit
ECO
34545422
Power cable
(US)
Upholstery parts
ECO
34545167
Detachable upholstery – 110 mm
ECO
34545407
Electronic control box with reading lamp connector
ECO
34545329
Slave control box
ECO
34545416
Reading lamp
(LED)
ECO
34545099
Upper upholstery
11. Spare Parts List
ECO
34545100
Lower upholstery ECO
34545101
Headrest pillow
ECO
34540300
Armrest strap for handset
Motors
ECO
34545008
ECO
34545381
ECO
34545192
Backrest motor
Legrest motor
Footrest motor
Parts for tilt-up armrest version
ECO
34545239
ECO
34545212
Upholstered armrest with edge protection
(with longitudinal adjustment)
Armrest mechanism for tilt-up version
ECO
34545220
Armrest mechanism for tilt-up armrest right
Mechanical parts
ECO
34545119
Central operating brake diam.:
10cm twin wheel castors
ECO
34545166
Upholstered footrest for 11 cm foam
ECO
34545141
Seat tilt motor
ECO
34545137
Seat height motor
ECO
34545213
Armrest height adjusting stirrup
ECO
34545221
Armrest mechanism for tiltup armrest left
Champion Mfg., Inc.
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