Bulletin - Braymer C

Cryo Therapy Chamber (–10/) –60°C/-110°C
Instructions for Use
Page 1 of 24
Manual_Ukraine.DOC
Contents
These Instructions for Use are an integral part of the Cryo Therapy Chamber
They must be kept at all times in the vicinity of the chamber. Accurate
observation is precondition for the use as intended and the correct handling of
the system as well as the safety of patients and users depending in these.
1. Purpose
2. Brief instructions on Operation
3. The Operator Interface of the System
4. Brief System Description
5. Display and Description of Console Operating Elements
6. Display and Description of Control Cabinet Operating Elements
7. Basic Setting
8. Contraindications
9. Warnings
10. Technical Data
11. Cleaning
12. Safety and Maintenance
13. Safety Checks
14. Declaration of Conformity
15. Scope of Supply/Accessories
16. Explanation of the Symbols
17. Error Messages/Troubleshooting
18. Addresses
Page 2 of 24
Manual_Ukraine.DOC
1. Purpose
System for whole-body cryo therapy and therapeutic indication in physical
therapy
The following effects have been observed:
•
Relief of pain, cessation of pain
•
Antiphologistic, immunomodulation
•
Reduction of increased muscular tension
•
Functional improvement of affected joints and muscles
•
Reduction / termination of irritation and decrease
•
of skin changes in certain dermatoses
•
Psychophysical activation
(See also further literature)
2. Brief instructions on Operation
Switching the system on:
1. Switch the main switch on the control cabinet on at least 24 hours before start of therapy.
2. Set the key switch on the control cabinet to "ON".
3. Bring the system into the wanted operating state using the touch screen operator interface.
Note:
Before the first therapy each day check the following functions:
 Are all doors closed?
 Is the lighting switched on?
 No fault messages on the monitor?
 Setpoint temperature reached?
 Display of the chamber temperature on the monitoring screen?
 Intercom system in operation, functioning in both directions?
 Chamber and console loudness correctly set?
 Video system in operation (pictures from the chambers)?
 Visual contact through window OK?
 Are the supply air / exhaust air opening free of snow (important to avoid fogging)?
Switching the system off:
1. Set the key switch on the control cabinet to "0".
2. Set main switch to "0".
Note:
As soon as the system is completely switched off all heaters are switched off (door and window frame
heaters, camera heater)
To avoid serious cold damage to the components, all doors of the chambers must be opened
immediately to heat up the chambers!
In the switched off condition mould and fungus can form if the doors are not opened (lack of fresh
air).
The chamber may be switched on again only if the humidity caused by condensation has been
completely removed and evaporated!
Page 3 of 24
Manual_Ukraine.DOC
3. The Operator Interface of the System
Please refer to the detailed documentation of the manufacturer for the further functions of the
Siemens touch panel used. The functions for therapy operation are described below:
Permanent window
The basic screen and the permanent window
Key description
The "Start Timer" key is for starting the therapy time or
stopping the therapy time
The "Reset timer" key is for resetting the timer to 0.0.
"Menu" key for switching from basic screen to the Menu screen
"Automatic" key for switching from automatic mode by time switch
to continuous operation, the system remains at therapy temperature.
"Light On/Off" key for switching the lighting in the rooms on and
off
ACK key acknowledges messages
The operating state of the system is indicated in the permanent
window in the upper part of the display.
The message window is displayed on occurrence of a fault.
If more than one message is active, then all messages are displayed one after the other.
If the 'ACK' key on the touch screen of the control cabinet RESET key is pressed, then the
basic software attempts to delete the message. If the error is not rectified, the corresponding
error bit is set again in the next program cycle.
Page 4 of 24
Manual_Ukraine.DOC
Menu screen
Menu
"Actual value" key branching into the actual values operating window
"Setpoints" key branching into the setpoints operating window
"Therapy time" key branching into the therapy time operating window
"ESC" key return to the basic screen
"System Off" key The system is switched off.
"System On" key The system is started and runs in automatic mode
"Faults" key branching into the operating window of the fault memory
"Thawing times" key branching into the thawing times operating window
"res" key without function
"Machine menu" key branching into the machine menu operating window
"Operating hours" key branching into the operating hours operating window
"Clean screen" key, this is intended for cleaning the touch screen surface, faulty
operating in prevented during the course of the time.
Page 5 of 24
Manual_Ukraine.DOC
Actual values / setpoints
The system data are displayed in the "Actual values" screen.
Actual values screen
Actual values
Temperature Anteroom 1
Temperature Anteroom 2
Temperature Therapy Room
LP1 low pressure stage 1 R507
HP1 high pressure stage 1 R507
LP2 low pressure stage 2 R23
HP2 high pressure stage 2 R23
LP3 low pressure stage 3 R14
LP3 high pressure stage 3 R14
Page 6 of 24
Manual_Ukraine.DOC
The temperatures and hystereses of the rooms are entered in the "Setpoints" screen
Setpoints
Temperature Anteroom 1
Temperature Anteroom 2
Temperature Therapy Room
Setpoint
Setpoint
Setpoint
-10°C
-60°C
-110°C
Hysteresis anteroom 1 On
Setpoint
1K
Hysteresis anteroom 1 Off
Setpoint
2K
Hysteresis anteroom 2 On
Setpoint
1K
Hysteresis anteroom 2 Off
Setpoint
2K
Hysteresis therapy room On
Setpoint
0.5K
Hysteresis therapy room Off
Setpoint
3K
Setpoint therapy room fan Setpoint
50-100%
Temperature example: Setpoint -110°C On 0.5 K Off 3K
System switches at –109.5°C On and at –113°C Off
Caution: At too high therapy fans setpoint freezing burns can occur.
This should be agreed with the Zimmer company before making
changes.
Page 7 of 24
Manual_Ukraine.DOC
The time in which the therapy chamber is in the therapy mode is stated in the "Therapy
time" screen
Caution, the chamber should be set 2h before therapy.
Therapy time
Switch-on time
System switches from standby to therapy
Switch-off time
System switches from therapy to standby
"Clock Off" key The clock can be switched on and on with this.
"Output On" key The output of the clock is enabled or disabled, the
clock runs on.
Clock On:
1 Output switched 0 Output not switched
Error: 0000 Clock works without error
Therapy time example: Therapy time should be from 8:00 - 17:00,
this from Monday to Friday
Setting:
Switching on: Day 8 Time 5.00h
Switching off: Day 8 Time 17.00h
Clock and output must be On.
Page 8 of 24
Manual_Ukraine.DOC
Thawing time menu
The time in which the therapy chamber is in the thawing function is stated in the "Thawing
time" screen.
Menu
"Thawing clock" Branching into the thawing times operating window
"Thawing limits" key branching into the Thawing limits window
"Forced thawing" key This initiates thawing
Caution: Thawing can be interrupted only by switching the system off.
"ESC" key Return to the basic screen
Page 9 of 24
Manual_Ukraine.DOC
Thawing times
The time in which the therapy chamber initiates thawing is stated in the "Thawing time"
screen.
Thawing time
Switch-on time
System switches from standby to thawing
Switch-off time
System switches from standby to stand
"Clock Off" key The clock can be switched on and on with this.
"Output On" key The output of the clock is enabled or disabled, the
clock runs on.
Clock On:
1 Output switched 0 Output not switched
Error: 0000 Clock works without error
Thawing time example: Thawing time should be from 22:00
Setting:
Switching on: Time 22.00h
Switching off: Time 22.05h
Clock and output must be On.
The thawing duration does not depend on the thawing time set but upon
the values entered in the window.
"Thawing limits".
Caution: The thawing time should not be longer than 10 minutes,
since otherwise the thawing will be restarted.
Page 10 of 24
Manual_Ukraine.DOC
Thawing limits
The maximum room temperature and the maximum thawing time are stated in the "Thawing
limits" screen.
Thawing limits
Anteroom 1
Anteroom 2
Therapy room
Setpoint
Setpoint
Setpoint
Max. 1800 sec
Max. 1800 sec
Max. 2700 sec
Thawing temperature anteroom 1
Setpoint
Max. 0°C
Thawing temperature anteroom 2
Setpoint
Max. -10°C
Thawing temperature therapy room Setpoint
Max. -30°C
Page 11 of 24
Manual_Ukraine.DOC
Faults
The existing faults are displayed in the "Faults" screen.
Page 12 of 24
Manual_Ukraine.DOC
4. Brief System Description
The Cryo Therapy Chamber consists of the two anterooms with functioning as locks and a main
chamber. The individual chambers are separated from one another by insulated cold room doors with
heated frames. The door from the -110°C therapy room to the outside (if available) is conceived
exclusively as emergency door. All chambers are provided with thermally regulated windows.
The evaporators of the first two rooms are located above the suspended aluminium panel ceiling.
The -110°C evaporator is housed in the technical room behind the therapy chamber.
The technical room is accessible through the service door fitted on the inside.
The therapy air is circulated through the stainless steel perforated sheet ceiling by three fans fitted on
the inside. Halogen lighting (4 x 20 W per chamber) is housed in the suspended ceiling.
All chambers are provided with heated special windows.
All chambers are monitored by video. The cameras are housed in the heated special housing. The
therapy chamber is equipped additionally with an intercom system.
The control console for the therapist is located in front of the chambers.
The entire refrigeration system (3-stage refrigeration cascade) is located in the machine room. The
control cabinet with the PLC (programmable logic controller) is located next top the refrigerating
machine.
All relevant system data can be queried for diagnostic purposes through a modem installed in the
control cabinet.
Page 13 of 24
Manual_Ukraine.DOC
5. Display and Description of Console Operating Elements
LCD Displays
Console loudness
Chamber loudness
Radio + CD
Microphone with
speech key
Touch panel
LCD displays
Display of the individual rooms.
Touch panel
Display of the temperatures, of the machine parameters and the
fault messages. Operation of the system.
"Console" loudness control
This control sets the loudness with which the operator at the
control console hears the patient in the chamber. A minimum
loudness cannot be exceeded in this case
"Chamber" loudness control
With this control you select the loudness with which your
microphone is heard in the chamber. To set this control you
require a second person in the chamber.
Microphone with speech key
You can give the patient in the chamber instructions with this
microphone. Press the speech key fitted on the side before
speaking.
Radio
The radio enables you to play music in the therapy chamber.
You can use radio stations or CDs as source. To set the
loudness you need a second person or information from the
patient.
(Observe the instruction for use of the radio.)
Page 14 of 24
Manual_Ukraine.DOC
Display and Description of Control Cabinet Operating Elements
Main switch
Emergency off button
Compressor
operating lights
Key switch
Acknowledge fault
Fault message
indicator
The control cabinet is located in the technical room. It has the following operating and display
elements:
Emergency shutdown switch
The self-locking emergency shutdown switch puts the entire
refrigeration system out of operation. To put the system back
into operation after this switch is operated, pull the switch out
again until it snaps into position. Then perform the items
"Acknowledge" and "Start-up" on the control panel of the PLC
according to chapter 17.
Key switch
The key switch enables the system to be secured against
unallowed use.
For maintenance work the system can thus be secured
effectively against being switched back on. The system may be
switched off only by using the key switch.
Main switch
The purpose of the main switch is to switch the entire system
on and off. The main switch may be switched only after the key
switch is operated.
Fault indicator
The red fault indicator flashes as soon as the system detects a
fault. Chapter 17 (Error Messages/Troubleshooting) contains
information about the procedure required in the case of a fault.
"Acknowledge fault" key
If there is no longer a fault, the fault message is acknowledged
here and the system runs on in the set operating state.
Compressor operating lights
The green operating lights indicate the perfect operation of the
individual compressors.
Page 15 of 24
Manual_Ukraine.DOC
The circuit diagrams of the system required for maintenance and service purposes are located in the
control cabinet. They are housed in a compartment behind the left cabinet door.
Note:
The control cabinet should be opened only by trained service personnel. The relevant functional
modules have to be accessible solely in the case of a fault for resetting the cause of the fault.
7. Basic Setting
The temperatures and the hystereses (size of the normal fluctuations) of the individual chambers are
preset in the factory.




Anteroom 1 (if present)
Anteroom 2
Therapy chamber
Standby temperature
-15°C
-60°C
-113°C
-60°C
Hysteresis 1 K
Hysteresis 1 K
Hysteresis 3 K
Hysteresis 25 K
The values for anteroom 1 and (if present) 2, therapy chamber and the standby temperature can be
changed for adaptation to the therapeutic requirements (see chapter 3, Operator Interface).
8. Contraindications
Whole body cryo therapy in the Cryo Therapy Chamber is not indicated for the following clinical
pictures
 Untreated blood high pressure disease
 Cardiac infarction (in the last 6 months)
 Arterial occlusion diseases in advanced stage
 Cryoglobulinemia
In any event therapy may be perform only on medical instructions.
9. Warnings
Please observe the following instructions when handling the Cryo Therapy Chamber and in the
performance of therapies.







Perform therapies only in consultation with the attending physician in each case.
Check the pulse and blood pressure of the patient before the treatment. In the case of abnormal
values there must be no treatment.
Before they enter the Cryo Therapy Chamber the patients must wear protection for the extremities
(gloves, mouth and ear protection) as well as socks and a sturdy pair of shoes. Swimwear is
recommended.
Jewellery, watches, spectacles and above all contact lenses must be removed before entering the
chamber.
Supervisory and trained auxiliary personnel must wear protection for the extremities and a sturdy
pair of shoes during the use of the therapy chamber.
Cold protection equipment for two further trained auxiliary personnel must be kept ready at hand
in the monitoring room.
Maintain visual and speech contact with the patients during the entire therapy.
Page 16 of 24
Manual_Ukraine.DOC





Observe especially attentively patients who shown a certain timidity before entering the chamber
as well as patients with claustrophobia.
Frail, old persons or persons who cannot walk properly, as well as persons with sensory and
perceptive disorders (e.g. poor vision or hearing, disturbed temperature sensation) may enter the
chamber only when accompanied by trained auxiliary personnel.
Before the therapy please instruct the patients about the correct behaviour in the chamber as well
as possibly occurring restrictions of vision due to fogging. Do not use the chamber if there is
intensive fogging.
Before the therapy instruct the patients about the lengthened expiration phase caused by the
expansion of the cold air in the lungs.
The patients should still move for a short time whole entering the chamber and also afterwards.
Never leave patients unattended in the therapy chamber!
10. Technical Data
Protection class
I
Application class
B
Design
Anterooms:
Walls made of 160 mm thick pressure-foamed polyurethane
hard foam panel and sheet metal galvanized on both sides with
PVC powder coating (2nd anteroom: inside panelling of wood,
natural beech, ventilated)
Floor covering of hardwood, surface structured slip-proof.
Ceiling of aluminium panels
Halogen low-voltage ceiling lights 4 x 20 W (per anteroom).
Therapy chamber:
Walls made of 160 mm thick pressure-foamed polyurethane
hard foam panel and sheet metal galvanized on both sides with
PVC powder coating
Floor covering of hardwood, surface structured slip-proof.
Inside panelling of wood (natural beech), ventilated
Ceiling of perforated stainless steel
Handrails of wood (natural beech)
Halogen low-voltage ceiling lights 4 x 20 W.
Note:
Doors:
Entrance door 1st anteroom (if present) with window, through
doors to 2nd anteroom and therapy chamber as well as
emergency exit without window (if present), large closing
lever, all door frame heated.
If the therapy chamber has been delivered without an
emergency door, the owner must ensure by providing
appropriate tools (e.g. emergency hammer, emergency axe,
etc) that in an emergency the window of the therapy
chamber can be smashed open.
Windows:
Thermally regulated windows in entrance door, 2nd anteroom,
therapy chamber, all windows heated.
Page 17 of 24
Manual_Ukraine.DOC
Refrigeration system
Weight
1800 kg
Refrigerant
R 507, R 23, R 14 (all CFC-free, nontoxic, non-combustible)
Electrical rating 40 kW
Power consumption
22 kW (maximum)
Connection
400 V, 50 Hz, 63 A, 3-phase
Permissible
temperature range
0-...37°C
Control
Therapy chamber
-110°C) ±5%
PLC
Therapy chamber
(programmable logic control)
-125...+20°C (typically
Anteroom 2
Anteroom 1
-70...+20°C (typically -60°C) ±5%
-20...+20°C (typically -10°C) ±5%
Air supply
Vertical, laminar (therapy chamber)
Air return
Through exhaust air slots at floor
level to the technical room
Video monitoring
Cameras in each chamber,
display on LCD displays
Intercom system
Loudspeaker/microphone in the
therapy chamber, continuously
transmitting from the chamber to the
control console without operation
Temperature indication Sensors in every chamber,
simultaneous display on a screen.
Accuracy ±2%
Page 18 of 24
Manual_Ukraine.DOC
11. Cleaning
The therapy chambers and the anterooms should be cleaned every 4 weeks or if required at shorter
intervals.
Perform cleaning work only if the chambers have assumed room temperature (>15°C) after the system
has been switched off. After cleaning with water and cleaning agents, the chambers must dry out and
be ventilated with doors opened and fresh air supply for around 8 hours.
Floor
Clean the floor damp with commercially available floor care
agents. In the case of greater contamination a wet cleaning unit
can be used. The floors of the monitoring and technical room
can also be cleaned damp with commercially available care
agents.
Walls
The PVC-coated metal walls can be wiped down with a
moistened soft cloth. Commercially available plastic cleaners
can be used in the solution for use stated by the manufacturer.
Note: Pay attention in this case to possible material
incompatibilities of the cleaning agent!
Wood panelling should be wiped down dry or with a slightly
moistened cloth. Do not use any cleaning or care additives.
Ceilings
Wipe down the ceiling panels of aluminium or stainless steel
dry or with a slightly moistened cloth. Commercially available
cleaning additives can be used.
Windows
You can use commercially available glass cleaning agents for
cleaning the windows.
12. Safety and Maintenance
The Cryo Therapy Chamber has been developed and manufactured corresponding to the applicable
standards and safety regulations. Zimmer Elektromedizin as manufacturer can consider itself
responsible for the safety and reliability of the system ,
- if the system is operated in agreement with the instructions for
use.
- if repairs, extensions, readjustments or changes are performed
only in cooperation with Zimmer Elektromedizin.
- if maintenance work is performed corresponding to the
instructions for use.
Page 19 of 24
Manual_Ukraine.DOC
Monthly maintenance The system must be thawed out and cleaned every 4 weeks. The following
work must be done in this case:
Wet clean chambers inside and outside
Clean windows inside and outside
Clean glass panes before the lenses of the video cameras.
Test for function and picture detail.
Vacuum condenser.
Test door seals, possibly also clean with glycerine and make
them supple.
Check perfect operation of the doors.
Put the chamber back into operation only when it is dry!
Half-yearly maintenance
The half-yearly technical maintenance must be performed
absolutely.
The maintenance must be performed according to exact
maintenance instructions and only by trained specialists of the
manufacturer (see chapter 18 Addresses).
Only spare parts the safety of which has been verified by the manufacturer may be used.
13. Functional Test (Safety Devices)
To assure the safety and the correct operation of the Cryo Therapy Chamber, checks of the chamber or
parts of it must be performed at predetermined intervals.
Before every therapy
Check the operation of the intercom system and of the
video monitoring.
Daily
Make sure that doors and closing levers can be moved easily.
Check the operation of the door frame and window heaters.
Check the plausibility of the indicated temperature values.
Monthly
Check the operation of the circuit breakers in the control
cabinet (Test key)
Annually
Check the individual elements of the lighting installation.
Note:
Replace defective lamps only by lamps of the same type and
same rating.
Page 20 of 24
Manual_Ukraine.DOC
14. Declaration of Conformity
It is herewith declared that the Cryo Therapy Chamber bears the CE marking
0123 in accordance
with the EC Directive for medical devices 93/42/EEC and fulfils the basic requirements of Annex I of
this directive.
The product has been classified as Class IIa in accordance with Annex IX of this directive.
15. Scope of Supply/Accessories
Scope of supply
The Cryo Therapy Chamber consists of the following elements:
Therapy chamber as treatment room
1 or 2 antechambers with air lock function
Technical room for evaporator and fans
Machine section in compact housing with control cabinet for
the control system
Condenser/heat exchanger for heat removal
CFC-free refrigerant (non-toxic, non-combustible)
Control with temperature monitoring and fault display
Video room monitoring
Intercom system
Music system
Uninterruptible power supply (UPS) for video room
monitoring, lighting and intercom system
Special equipment
Heat recovery for domestic and swimming pool water
Accessories
protection)
Extremities protection (mouth protection, gloves, ear
16. Explanation of the Symbols
Affix warning sign "Wear extremities protection"
well visibly to the chamber for safe therapy operation.
Page 21 of 24
Manual_Ukraine.DOC
Page 22 of 24
Manual_Ukraine.DOC
Symbol: "Application part Type B"
is depicted on the nameplate of the chamber.
17. Error Messages/Troubleshooting
In the event of a fault an error message appears in plain language on the monitoring screen and on the
touch screen of the PLC (control console). In addition the designation of the corresponding
components according to circuit diagram appears.
Fault rectification
Sometimes the error can be eliminated by resetting the fault
function. For this purpose press the Reset key on the function
module in the control cabinet stated in the error message.
Thy system can frequently be put into the fault-free state
by completely switching it off and back on.
Note:
The system may be switched off and back on only with the key
switch on the control cabinet. The main switch of the system is
not designed as power switch!
Acknowledgement
In any event the fault must be acknowledged on the PLC. Press
the "ACK" key for this purpose.
There is no possibility of acknowledgement as long as the cause
of the error is not yet rectified.
You will find detailed information on the error messages in the
Technical Documentation of the Cryo Therapy Chamber.
Putting into operation
After the fault has been rectified the system will restart
operation with a time delay by renewed operation of the "ACK"
key.
Service
Should it not be possible to acknowledge the error messages
because fault rectification is not possible, please contact
Zimmer Elektromedizin or L & R Kältetechnik. For this
purpose keep ready the noted error message as well as further
information about the circumstances of the fault (operating
mode of the system, operating duration, unusual occurrences in
operation, ...).
Page 23 of 24
Manual_Ukraine.DOC
18. Addresses
Manufacturer:
Zimmer Elektromedizin GmbH / Mr. Brinkmann
Junkersstraße 9
D-89231 Neu-Ulm
Tel.:
0731 97610
Fax:
0731 9761118
email: [email protected]
Service:
L.u.R. Kältetechnik / Mr. Fischer
Hüstener Strasse 43-45
D-59846 Sundern/Sauerland
Tel.:
02933 97570
Fax:
02933 975795
email: [email protected]
Page 24 of 24
Manual_Ukraine.DOC
`