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
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