Manual KanMed Operatherm

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Users Manual KanMed Operatherm 202 /200

Contents
1. 2 3 4 5 6 7 8 9 10 INTENDED USE.......................................................................................................................... 2 SAFETY INSTRUCTIONS........................................................................................................... 2 TECHNICAL SPECIFICATIONS ................................................................................................. 5 DESCRIPTIONS OF FUNCTIONS.............................................................................................. 6 USING THE UNIT........................................................................................................................ 9 CHECKING OF SAFETY SYSTEMS ........................................................................................ 10 ACCESSORIES AND SPARE PARTS ...................................................................................... 11 EMC COMPATIBILITY STATEMENT ....................................................................................... 11 WARRANTY STATEMENT. ...................................................................................................... 11 MAINTENANCE ........................................................................................................................ 12

NOTE: Patient warming equipment can harm the patient if not used correctly. Never use a unit that do not perform the Self Test according to this manual Make sure that the performance of the unit is regularly checked. This manual contains important information and must be kept for future reference. It is valid for all Operatherm 202 / 200 units. Manufactured by: KanMed AB, Grdsfogdevgen 18B, SE-168 66 Bromma SWEDEN Tel no: +46 8 564 80 630 Fax no: +46 8 564 80 639

Users instruction
KanMed Operatherm 202
0413
Art. Nr.:OP-202-050 / 5

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1. INTENDED USE
The intended use of the Operatherm 202 / 200 is to prevent or minimise heat loss from patients in the Operating Room. The Operatherm must be used in compliance with the instructions in this manual and in accordance to accepted hospital and clinical routines.

SAFETY INSTRUCTIONS
Please read the complete user manual carefully before using the equipment.

WARNING
Never use a unit that do not perform the Self Test according to this manual. Never use a unit that has been dropped or fallen onto the floor before it has been examined by a qualified technician The Operatherm 202 is a very safe equipment. However certain combinations of heat, pressure, long term surgery and disinfectant fluids can cause skin damage. Therefore it is important to observe the advice regarding pressure relief, excessive fluid and temperature selections given later in this section.

2.2 EXPLANATION OF SYMBOLS

Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide Protection grade BF, Defibrillation safe See users manual

AC current DC current ON OFF switch. / IPX1 / IPX7 Drip proof, Control Unit Water tight, Heating Pad

0413

Fullfills MDD 93/42 EEC. EC-Type examination certificate issued by a Notified Body ( 0413= Intertech SEMKO, Sweden)

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Key switch for temperatures <35C and >37C Temperature selector switch Alarm silence switch Heating Pad failure alarm

Over temperature alarm

Control Unit failure Earth potential equalisation connection point

2.3 EXPLANATION OF PICTURES ON THE HEATING PAD

1 2 3 4 5 6 7 8 9 10 11

Refer to users manual Heating Pads OP-200-xxx may only be used with Operatherm Control Unit OP-200/202 Unauthorised persons are not allowed to open the Control Unit or the Heating Pad Connector. Any such interventions may endanger the patient safety. The Heating Pad cable may not be altered in length or repaired in any other way. See Users Manual section 10, concerning cleaning and maintenance of Heating Pads and Control Units Sharp objects must not penetrate the Heating Pad Place the Heating Pad flat on the operating table with the text side towards the patient. Gel Pads must be placed over the Heating Pad. When used with children, ensure that the gel pad Gel Pads covers the whole Heating Pad Ensure that the text side of the Heating Pad is towards the patient or ECG disturbance may occur. The Heating Pad should be stored using the Pad Hanger or rolled with a diameter not smaller than 150mm. Don't bend or fold the Heating Pad so that sharp crease arises.

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2.4 DIATHERMY EQUIPMENT AND DEFIBRILLATORS

During normal use the Operatherm is not disturbed by this equipment. However, if diathermy or defibrillation is set at very high outputs, the Operatherm might go into alarm state. In such a case, switch off the Operatherm and restart and observe that the self test performs as usual. Note that housing including handle of control unit is electrically connected to earth.

2.5 ECG EQUIPMENT

Warning: Under unfavourable conditions there is a risk of interference occurring on ECG traces if ECG electrodes are not applied strictly to the manufactures instructions or if the Heating Pad text side is facing downwards. In most cases the problem is solved by making sure that the correct ECG cables and electrodes are being used and by ensuring that the electrodes have proper skin contact.

2.6 FLUIDS BETWEEN THE PATIENT AND THE HEATING PAD

Any collection of fluids, especially disinfecting fluids, can cause skin irritations.

2.7 ALWAYS USE GEL PADS

The Operatherm Heating Pad shall be covered with Gel Pads. For operations that will last many hours and for patients sensitive to pressure (f.i. diabetes), the combination of immobility, skin pressure and warming may prove an bad combination and you may consider not to use the Operatherm at all. KanMed Gel Pads will achieve a surface temperature that is about 1-2C lower than the selected Heating Pad temperature. The Gel Pads will also increase the contact surface and thereby increase the amount of heat transferred to the patient

2.8 TEMPERATURE SETTING

Under normal conditions and with KanMed Gel Pads under the patient the maximum temperature 39C should be selected. During long interventions one must consider a lower temperature setting. If the OR-table surface is hard, blood pressure is low i.e. bad circulation, old patients, patients with diabetes, etc. 37C should be the highest temperature.

2.9 USE WITH CHILDREN AND PRE-TERM BABIES

Small children, especially pre-term babies, are easily influenced by surrounding temperatures. They can get cold fast or may get fever by being warmed too much. Never ever use the Operatherm without gel pads especially when treating a child. A Gel Pad acts as a heat buffer and assures an even heat distribution as well as increased heat transfer and comfort.

2.10 AREAS WITH NO BLOOD FLOW

By planned internal vessel shut off the Heating Pad must be placed where heat is mostly needed. Heat supply to tissue with no blood flow may increase the risk of tissue damage. Place the pad where there is circulation alternatively shut the Operatherm off during the period of no blood flow.

2.11 PRE-WARMED GEL PADS

Pre-warmed Gel Pads are very efficient warmers and should preferably be heated to 42C. KanMed Gel and Fluid warming Cabinet is made for this purpose. At 42C there is a very small chance that the warm gel pads may trigger the over temperature alarm of the Operatherm. If so happens, wait about 10 minutes before switching on the unit again.

2.12 HEATING PAD CONNECTION CABLE.

Never alter the length of the pad cable or repair the pad cable or the pad connector. The pad will afterwards have an incorrect temperature, which might be higher than displayed on the Control Unit. Never change the electronics in the Heating Pad connector.

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TECHNICAL SPECIFICATIONS
Art. no.:OP-200-002 30 Volt DC 200 Watt L 1040 mm W 450mm H 2 mm 2 kg 3,5 meter approx. ( Other lengths may be ordered ) Watertight, except connector Not electrical conductive Art. no.: OP-200-012 30 Volt DC 100 Watt L 630 mm W 430 mm 2 mm 1,5 kg 3.5 metre approx. (Other lengths may be ordered) Watertight, except connector Not electrical conductive Art. no.: OP-200-221 30 Volt DC 200 Watt L 1500 mm W 450 mm H 2 mm 3,5 metre approx Watertight, except connector Not electrical conductive 220 -240 V AC ( 100 and110-120 V AC is also available ) 50/60 Hz 285 VA (max) 32C and 35-39C in steps of 0.5C 0.5C LED 0.5C 40,25C 0.75C L 255 mm approx. W 150 mm approx H 120 mm approx 5 Kg approx. 220 - 240 Volts T 4A, 110 120 Volts T 8A Continuous about 8-10 minutes at room temperature about 25 minutes when tested under conditions of ADEQUATE HEAT DISCHARGE (IEC601-2-35) : 15C - 40C -20C - + 60C 10 - 85 % non condensing EN60601-1, EN60601-1-2, IEC60601-2-35 BF, Defibrillator safe Class I Class IIB
0413

Heating Pad Standard Voltage Power Dimension Weight Length of cable Water protection Surface, electrical properties Heating Pad Small Voltage Power Dimension Weight Length of cable Water protection Surface, electrical properties. Heating Pad 150cm Voltage Power Dimension Weight 2,8 kg Length of cable Water protection Surface, electrical properties Control Unit Voltage Frequency Power Temperature range Accuracy Indicators Resolution Over-temperature alarm level Dimensions Weight Fuses Mode of use Heating up time Elements inside the Heating Pad Heating Pad surface Environment Operating temperature Shipping and storage Relative humidity Safety Standards Protection type Protection class MDD classification

NOTE: Specifications are subject to changes at any time.

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DESCRIPTIONS OF FUNCTIONS
The Control Unit contains a microprocessor based heating control system that regulates the temperature of each of the 8 (4) elements in the Heating Pad. The temperature is continuously monitored and the average temperature is displayed in steps of 0.5C by the temperature LED's. The safety system in the Control Unit is continuously monitoring the main voltage, internal voltages, run parameters, the pad connection, the pad condition and the temperature of each element. A safety circuit, totally independent of the microprocessor based operating system, can at any time stop the warming should conditions occur that can cause over temperature. If a fault is detected the Control Unit will alarm visually and acoustically and switch off the heating. The type of alarm is indicated on the alarm display. It may be pad fault, Control Unit fault, over-temperature or a combination.

4.1 THE CONTROL UNIT

4.2 SELF TEST

Every time the Operatherm is switched on it will perform a self-test of all functions including the internal safety-circuit. This is how the self test runs: When pressing the ON /OFF button all front panel indicators and the beeper are activated. After about 0.5 sec the red ALARM indicators and the beeper are turned off. About 2 sec. later temperature indicators are turned off. Simultaneously the red indicators and the beeper are activated again for about 2 seconds. This indicates that the safety-test has been successfully completed. The Operatherm will then automatically start at 37C, providing the self test went well.

Do not use the unit if the self test does not perform correctly!
If a fault is detected during the test the Operatherm will not start automatically and the type of fault be indicated by the corresponding alarm LED and the acoustic alarm will sound. Switch off the unit and check heating pad connection. Switch on the Operatherm again. If it still alarms then switch it off and contact a qualified technician.

4.3 LAYOUT FRONT PANEL

1 2 3 4 5 6 7 8 Over-temperature Pad fault CU. Fault Temperature Selection button Key switch for temp. >37C and 32C To cancel alarm Heating Pad connector ON/OFF button

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4.4 TEMPERATURE INDICATION

Selected and actual pad temperature is indicated. The selected value is indicated by a continuously lit LED. Actual temperature - if different from the selected - is indicated by a flashing LED. In case the pad temperature is lower than 32C or higher than 39C respective LED will flicker.

4.4.1 TEMPERATURE SELECTION

The control unit automatically selects 37C as start temperature (default). Use temperature selection button to change within the range 35C - 37C. Pressing the Key switch + temperature selection button allows temperatures up to 39C or 32C. This is a safety feature to prevent unintended selection of temperatures outside the range 35-37C.

4.5 ALARM FUNCTIONS

Operatherm supervises the following fault conditions Over-temperature

Pad fault Control Unit fault These alarms are indicated by a red light under each symbol and an acoustic alarm.

4.5.1 OVER-TEMPERATURE ALARM

This alarm will be activated if any one or more of the 8 elements in the standard and long pad or of the 4 elements in the short pad should become warmer than 40,25C. The visual and acoustic alarm will be activated and the over heated element(s) will be switched off for 90 sec. The acoustic alarm can be reset but the over-temperature indicator will stay lit. If, during the 90 sec. period, the temperature of the alarming element (s) drops below 40,25C the visual alarm will automatically cancel itself and Operatherm will continue to operate as usual. If, after 90 sec, the temperature of any element remains above 40,25C + - .75C the acoustic alarm will be activated again and can only be cancelled by switching the unit off.

4.6 HEATING PAD

The standard Heating Pad and the 150 cm Pad consists of 8 individual heating elements and the shorter heating Pad OP-200-012 of 4 individual elements. Each element is regulated separately. Thanks to this unique feature the heat is supplied to the part of the pad where it is most needed. The individual elements are insulated from each other with a Mylar plastic foil. They are hermetically sealed into the soft hospital grade yellow foil. They are watertight and easy to clean. The voltage in the elements is only 30 Volts DC. The pad is connected to the front of the Control Unit.

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4.6.1 HEATING PAD ALARM

This alarm will be activated if the pad is not connected, or not properly connected, or if any of the 8 (4) heating elements deviates from normal electrical resistance, or if there is a fault in the connecting cable, in the pad connector or in the regulator power switch. In case of a pad failure being detected during the self-test, the Operatherm will not warm until the pad failure has been corrected. If, during use, a pad fault occurs that affects 3 or more of the 8 heating elements the unit will alarm visually and acoustically and switch off the heating. On short pads the heating will be switched off if 2 or more of the 4 elements are faulty. In case the fault affects maximum 2 of the 8 elements or 1 of the short Pad elements, the unit will alarm visually as follows: 1 element faulty - slow flashing Pad fault LED 2 elements faulty - slow double flashing Pad fault LED If the Heating Pad gets disconnected during normal use, the pad fault indicator and the 32oC LED will be lit. The beeper will also sound. Switch the unit off and reconnect the Heating Pad. Restart the unit and observe a correct self test.

4.7 CONTROL UNIT FAULT

Any fault in the Control Unit will lit the Control Unit fault symbol and activate the acoustic alarm. The heating will be switched off. Switch the unit off and try a restart. Observe that a correct self test takes place and that the unit behaves normally and indicates temperatures as described in this manual. If in the slightest doubt about the correct function of the unit, do not use it. Contact a qualified technician.

4.8 MAINS FAILURE ALARM

In case of a mains failure, the Operatherm alarms by flashing the C. U. LED and sounding the beeper intermittently. The mains failure alarm is kept active for at least 10 min. After return of the mains power the Operatherm restarts with a self test and at the temperature selected before the mains failure occurred.

4.9 REAR-PANEL
The rear-panel contains information about manufacturer, serial number, voltage, fuses, etc. Mains cord is also connected here.

FIG. 2 REAR PANEL

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USING THE UNIT

5.1 PREPARATIONS.
The Heating Pad Place the pad on the OR-table and make sure it is not folded. Cover the Heating Pad with Gel Pads, preferably pre warmed and a sheet. (See also chapter 2) Connecting the Heating Pad Connect the pad to the control unit and make sure that the connector engages correctly. Secure the connector with the safety clips. Mains Connection Connect the unit with the supplied mains cable or that supplied by your medical technical department. Placing the Control Unit Place the Control Unit where it can easily be observed. It can be hung on it's handle. Note the handle and the enclosure is electrically connected to earth.

5.2 START
Switch on the unit and observe the Self Test. Check that the beeper and ALARM indicators are activated shortly (approx. 0.5 sec) and that all temperature LED's will be lit for approx. 2 sec. Then they go out and the alarm indicators will instead be lit and the alarm shall sound. This indicates that Operatherm has made a self test, a pad test and a test of the safety functions. The heating of the pad will now start automatically at 37C (default).

NOTE: If the unit do not react as described above it must not be used and shall be examined by a technician.

5.3 SELECTING TEMPERATURE

In case you wish to select another temperature than 37C then do as described in chapter 4.4.1 It will take about 8 15 minutes for the elements in the pad to reach the set temperature depending on surrounding conditions.

NOTE: Please refer to section 2 regarding choice of temperature.

5.4 GEL PADS

Always use Gel Pads to get an even heat distribution, a greater contact surface and to minimise the risk of pressure sores. KanMed Gel Pads are best suited for this purpose. Always place the Gel Pad on top of the Heating Pad. A sheet can be placed between the Gel Pads and the patient. It is advantageous to pre-warm the Gel Pads to maximum 42C by, for instance the KanMed Gel Warming Cabinet. A cold Gel Pad will drain heat from the patient during the first 20 -40 minutes. This is the time it takes for the Operatherm to warm a KanMed Gel Pad (with a patient lying on it) to skin temperature. After about one hour the skin temperature will be in the region of selected temperature less 1-2C.

5.5 WARM START

Avoid placing the patient on cold Gel Pads and a cold Heating Pad. Operatherm is designed to be left switched on continuously so that it can warm gel pads and be ready for use at any time. If you have no reliable warming cabinet it is possible to roll the Heating Pad with Gel Pads to get a faster warming up. It can even be left like that so that everything is properly warm for the next patient.

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5.6 ALARMS
In case the Operatherm alarms, observe the alarm type indicated and switch the unit off. Try to eliminate the cause for the alarm. Restart the unit and observe a correct self test. In case the alarm comes back without an apparent reason the unit must be checked by a technician.

CHECKING OF SAFETY SYSTEMS

SAFETY SYSTEMS AVAILABLE
Alarms will be activated in any of the following situations: 1 Self test when the unit is switched on 2 Mains power failure alarm and restarting 3 Faults in the heating pad 4 Over-temperature 5 Technical faults arising during use (cannot be tested by the user) The safety system can be tested as follows below.

6.1 TESTING THE SAFETY SYSTEM

6.1.1 SELF TEST WHEN THE UNIT IS SWITCHED ON Connect the Heating Pad to the control unit and the control unit to the mains. Switch on the unit and check that:
-The beeper beeps shortly (0.5 sec) -That, all temperature indicators are lit for about 2 seconds. -That after the 2 sec. all red ALARM indicators and the beeper are activated for 2 seconds. -That the heating starts automatically at 37C.

6.1.2 MAINS POWER FAILURE ALARM AND RESTARTING Connect the Heating Pad to the Control Unit and the Control Unit to the mains. Switch on the unit and wait for the self test to be completed. Disconnect the power cord.
- The alarm shall sound for at least 10 minutes. Reconnect the power cord The unit shall perform the self test and then warm at the temperature that was selected before power off.

6.1.3 FAULTS IN THE HEATING PAD

Connect the Heating Pad to the unit and the control unit to the mains. Switch on the unit and wait for the self test to be completed. Disconnect the Heating Pad and check that the red pad LED is lit and that the buzzer sounds. Switch the unit off and reconnect the Heating Pad. Restart the unit and observe a correct self test. Reconnect the Heating Pad and press the ALARM button. Check that the heating has resumed. NOTE: This is the intended reaction of the Operatherm control unit to a disconnected Heating Pad. There is however a small possibility that the Control Unit will react differently in case the Heating Pad happens to be disconnected during a non heating period of the electronics. In this case both red and yellow indicators might be lit. If this happens, heating cannot be restarted by pressing the ALARM button. Instead you have to switch the mains switch off and on again.

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6.1.4 OVER-TEMPERATURE Connect the Heating Pad to the Control Unit and the Control Unit to the mains. Switch on the unit and wait for the self test to be completed. Select 39C Roll the Heating Pad (diameter more than 15 cm) and put the pad or part of the pad into for instance a
bucket of lukewarm water. It is enough to dip approx. 1/2 of the Pad under the water. Check the water temperature Slowly add warm water. When the temperature has reached 40,25C +- 0.75C the over-temperature indicator shall be lit and the buzzer shall sound. NOTE: It may take a minute or two for the Heating Pad to assume the water temperature, therefore rise the water temperature slowly when approaching 40,25C.

ACCESSORIES AND SPARE PARTS

STANDARD DELIVERY
A normal delivery normally includes a Control Unit, User manual in your language, various Heating Pads, Heating Pad hanger, Power Cord and Gel Pads. Manuals can be downloaded from www.kanmed.se For information about accessories and spare parts please see www.kanmed.se or contact your local dealer.

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EMC COMPATIBILITY STATEMENT

Please see www.kanmed.se section downloads Operatherm

WARRANTY STATEMENT.
KanMed warrants the purchaser that the Operatherm Control Unit and Heating Pads shall be free from defects in material and workmanship for a period of 12 month from the date of purchase. The sole obligation of KanMed with respect to any such defect is limited to the repair with new or remanufactured parts or, at the discretion of KanMed, replacement of the equipment or refunding of the purchase price. This warranty shall not apply if the product has been modified, adjusted or repaired other than by KanMed or by organisations authorised by KanMed or modified, adjusted or not repaired in accordance with written instructions provided by KanMed or if the equipment has been subject to misuse, negligence or accident. These warranties are made on the conditions that prompt notification of a defect is given to KanMed or its authorised dealers within the warranty period. KanMed shall have the sole right to determine whether a defect exists. KanMed shall not in any case be liable for special or consequential damages arising from the breach of warranty, breach of contract, negligence or any other legal theory.

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10 MAINTENANCE
10.1 CLEANING / DISINFECTING
WARNING: Always disconnect mains power cord before any cleaning procedure. THE CONTROL UNIT Wipe off with a moist cloth and if necessary use your normal cleaning agent. THE HEATING PAD: Clean the watertight Heating Pad with soap or your usual cleaning agent. Disinfect the pad with alcohol or any other disinfectant. NOTE: Do not autoclave the pad. Do not submerge the connector in any liquid. In case liquid enters the pad connector, the technical department should be contacted for checking and if required repairing.

10.2 PERIODICAL INSPECTIONS AND CHECKS

ACTION
Inspections carried out by the user/operator.

INTERVAL

Self test at Power ON Visual inspection of pad, cable and connector

Every time the equipment is switched on. Before every use

Checks carried out by technical personnel. Alarm functions Mains failure Pad failure Over-temperature Temperature control Electrical safety Exchange of connector saver

Once a year

Once a year Once a year Once a year

10.3 STORING
The Heating Pad shall be stored hanging or lying flat. Avoid folds that may shorten the lifetime.

10.4 TECHNICAL DOCUMENTATION

The supplier will make available on request circuit diagrams, component parts lists, descriptions, or other information which will assist the user's appropriately qualified technical personnel to exchange those parts of the equipment which are designated by the manufacturer as exchangeable. Only the KanMed factory is authorised to perform repairs on the main PCB.