Medi-Therm® III Hyper/Hypothermia Machine
Contents
1. ON DMN KRW o Medi Therm and Clik Tite are registered trademarks of Gaymar Industries Inc 2007 Gaymar Industries Inc All rights reserved www gaymar com Medi Therm III 1 0 Safety Precautions Read and understand this operating manual and all precautions listed below prior to using the Medi Therm III Hyper Hypothermia Machine A DANGER Do not use the Medi Therm IIl machine in the presence of flammable anesthetics Risk of explosion can result A WARNING If the patient s temperature is not responding or does not reach the prescribed temperature in the prescribed time or deviates from the prescribed temperature range notify the attending physician promptly Failure to notify the physician promptly may result in serious injury or death Power interruption will cause the Medi Therm III machine to go into a standby mode resulting in no therapy to the patient Follow instructions for desired mode to resume operation Failure to resume therapy could result in serious injury or death When performing the PROBE CHECK p 17 10 1 2 item 4 use a protective sheath on the probe Failure to use a sheath could result in cross contamination A physician s order is required for use of equipment Check the integrity of the skin according to department protocol when regulating temperature with external devices Frequency of assesment and documentation will vary depending upon the individual response o2. GAYMAR Medi Therm 111 Hyper Hypothermia Machine MTA7900 Manual Mode Automatic Mode Monitor Mode LISTED 303L STANDARD NORME C22 2 No 125 RISK CLASS CATEGORIE DE RISQUES NO 2G Operator s Manual U S PATENT NO 6 517 510 CANADIAN PATENT NO 2 411 539 P N 100311000 8 07 Before you begin Medi Therm III Important Table of Contents Read and understand this Medi Therm III Operating Manual and all Safety Precautions see page I section 1 0 and 13 14 section 8 0 prior to using the Medi Therm Ill 2 0 Description Hyper Hypothermia Machine Section Description 1 0 Safety Precautions 3 0 Features 4 0 Operator Control Panel 5 0 Start up Procedure 6 0 Shutdown Procedure 7 0 Modes of Operations Manual Mode Automatic Mode Monitor Mode Patient Safety Receiving Inspection Care of Medi Therm III Alerts Troubleshooting Refer to the Medi Therm III Service Manual for Receiving Inspection and Check out Procedures Blankets Accessories Customer Training If you have any questions contact Gaymar s Warranty Technical Service Department for assistance Telephone 1 800 828 7341 716 662 2551 716 662 8795 Illustrations Description Medi Therm III System Medi Therm IIl Features Medi Therm 111 Control Panel Pinch Clamps A CAUTION U S Federal law restricts this device to sale Quick disconnects by or on the order of a physician Clik Tite Connector
3. If possible remove the probe from patient contact before activating the surgical unit or other RF source If probes must be used simultaneously with electrosurgical apparatus hazards can be reduced by selecting a temperature monitoring point which is remote from the expected RF current path to the ground return pad A CAUTION Fill with distilled water only Failure to use distilled water may result in poor machine performance Do not use alcohol Alcohol may accelerate blanket body wrap deterioration Do not operate without water since damage to internal components may result Do not overfill Overfilling may result in overflow because the water in the blanket body wrap drains back into the machine when the machine is turned off Place a dry absorbent sheet between the patient and the blanket when using the plastic like side of any blanket Moisture may accumulate which may result in skin damage Description Medi Therm III control panel Medi Therm III machine Quick disconnects on machine end connector hose Use only Gaymar probes or equivalent YSI 400 series probes approved for use with medical devices Hyper Hypothermia blanket body wrap Clik Tite connector Clik Tite connectors and representative hose clamps Figure I Medi Therm III Hyper Hypothermia System 2 0 Description This manual describes the operation of the Medi Therm Ill Hyper Hypothermia machine The Me
4. 1238 Nov 1969 Stewart T P and Magnano S Burns or Pressure Ulcers in the Surgical Patient Decubitus Vol pp 36 40 1988 Llorens Alfred S Reaction to Povidone lodine Surgical Scrub Scrub Associated with Radical Pelvic Operation Am J Obstet Gynecol pp 834 835 Nov 14 1974 Hodgkinson Darryl J Irons George B and Williams Tiffany J Chemical Burns and Skin Preparation Solutions Surgery Gynecology amp Obstetrics Vol 17 pp 534 536 Oct 1978 Medi Therm III Care of Medi Therm 111 9 0 Care of Medi Therm III NOTE The Medi Therm 11 control panel and top surfaces can be cleaned with a soft cloth As with any precision equipment proper care and lightly dampened with isopropyl alcohol maintenance will insure proper performance and reliability The following routine maintenance procedures Clean up any accidental spills will help insure dependable Medi Therm lll operation immediately use a cloth lightly dampened with isopropyl alcohol 9 1 Machine Care You may check for clarity of fluid by viewing water flowing through clear vinyl WARNING biben Do not tip machine over without first draining the water out and unplugging the power cord 9 2 Blanket Care Damage to the machine or electrical shock Allow the blanket body wrap to remain can result connected to the Medi Therm III machine for about 10 minutes after the machine has been turned off This will allow most of the water A
5. Automatic Mode When WARMING the patient RAPID the highest allowable water temperature is used for warming as high as 42 C 107 6 F This is the fastest warming mode the machine can provide MODERATE The patient temperature will increase at a rate of 1 1 8 F in a period of 3 hours 0 33 C Hr 0 6 F Hr GRADUAL The patient temperature will increase at a rate of 1 C 1 8 F in a period of 6 hours 0 17 C Hr 0 3 F Hr A WARNING Check the integrity of the skin according to department protocol when regulating temperature with external devices Frequency of assessment and documentation will vary depending upon the individual response of the patient Failure to monitor patient may result in skin damage or inappropriate patient temperature If the patient probe senses an abnormal patient temperature below 29 C 84 2 F or above 45 C 113 F therapy will stop the CHECK PATIENT PROBE alert will light and an audible alarm will sound This condition may indicate the patient probe has become dislodged an incorrect probe is being used or the probe has become defective see Alerts pp 17 18 NOTE The PATIENT temperature display will begin to flash the ALERT LED will flash and the audible alarm will toggle when the patient s temperature deviates by 0 C 1 8 F or more from the desired warming rate selected Modes of Operation Monitor Mode Medi Therm III MEDI T
6. CAUTION to drain back into the machine Reusable all vinyl blankets should be cleaned with a damp cloth and mild detergent If blankets must be sterilized use any cold sterilization means except alcohol Exposure to harsh chemicals will cause blankets to Do not use alcohol Alcohol may accelerate lose flexibility and reduce their resistance to blanket body wrap deterioration Alcohol is cracking flammable Add distilled water only Failure to use distilled water may result in poor machine performance When storing reusable all vinyl blankets they Do not operate without water since damage to should be rolled loosely Do not allow to internal components may result freeze Single patient use blankets and body wraps should be discarded after use Do not overfill Overfilling may result in overflow because the water in the blanket body wrap drains back into the machine when the machine is turned off Reusable all vinyl blankets can often be repaired using a vinyl patch kit Do not return blankets to factory for repair Do not use bleach Bleach will damage the 9 3 heating element which could result in excessive leakage Do not autoclave If probe must be sterilized use any cold sterilization means except alcohol which may accelerate probe deterioration Always wipe dry Probe Care Reusable probes may be cleaned with a damp cloth and mild detergent Always wipe dry Exposure to harsh chemicals will caus
7. the CHECK PATIENT PROBE alert will light and an audible alarm will sound This condition may indicate the patient probe has become dislodged an incorrect probe is being used or the probe has become defective see Alerts pp 17 18 The CHECK PATIENT PROBE alert will turn off and the audible alarm will silence when the patient temperature returns to the range of 29 C 84 2 F to 45 C 113 F Modes of Operation Automatic Mode Medi Therm III EAGAYMAR To control WATER temperature Connect blanket s Press MANUAL button Set desired water temperature To control PATIENT temperature Connect blanket s Insert patient probe Press AUTO button Press again to select CONTROL OPTION Set desired patient temperature To monitor PATIENT temperature TEST LIGHTS SILENCE AND ALARM ALARM MONITOR e NO THERAPY Insert patient probe AN Press MONITOR button MEDI THERM III Patient CONTROL Set Point Figure 9 Automatic Mode 7 2 Automatic Mode To Control Patient Temperature When operating in the AUTO mode the Medi Therm III automatically regulates the patient s temperature to the selected SET POINT The machine constantly compares actual patient temperature with the SET POINT value and automatically adjusts the water temperature so that the desired patient temperature is achieved To operate in AUTO mode 1 Perform all start up procedures pp 5
8. 7 Insert sensing end of patient probe into patient and tape securely to prevent accidental dislodgment Insert plug end of patient probe into PATIENT PROBE jack NOTE Make sure probe plug is fully seated Use only GAYMAR probes or equivalent YSI 400 series probes approved for use with medical devices If in doubt that the correct probe is being used and is operating properly perform a PROBE CHECK test p 17 10 1 2 item 4 YSI 400 Probe or equivalent O Press the AUTO mode button The window on the top of the AUTO button will light The CONTROL OPTION RAPID will light NOTE To prevent accidental triggering of the CHECK PATIENT PROBE alert place probe in patient and wait for patient temperature to stabilize before pressing AUTO mode button The WATER display will be blank when operating the Medi Therm IIl in AUTO mode The PATIENT display will indicate patient temperature The SET POINT temperature will indicate the default temperature 37 C 98 6 F at start up until selecting the SET POINT temperature in step 6 p 11 O If desired change the temperature scale by pressing the C F button Medi Therm III Q Adjust the SET POINT display to the prescribed patient temperature setting by pressing the V or A button to decrease or increase the SET POINT NOTE When the Medi Therm Ill machine is turned on the machine set point defaults to 32 C 89 6 F when MANUAL mode is
9. HERIM II EAGAYMAR e SELECT MODE To control WATER temperature a TEMPERATURE N Connect blanket s Press MANUAL button Set desired water Patient MANUAL temperature To control PATIENT temperature CONTROL Connect blanket s b Insert patient probe Press AUTO button Press again to select Set Point CONTROL OPTION Set desired patient temperature To monitor PATIENT temperature NO THERAPY Insert patient probe AN Press MONITOR button TEST LIGHTS SILENCE MONITOR AND ALARM ALARM YSI 400 robe or equivalent 7 3 Monitor Mode Patient Temperature Monitoring No Therapy Figure 10 Mode Press MONITOR mode when no patient temperature therapy is required but monitoring of patient temperature is desired To operate in MONITOR mode Perform steps 5 4 and 5 5 of the Start up Procedure pp 6 7 Insert sensing end of patient probe into patient and tape securely to prevent accidental dislodgment e Insert plug end of patient probe into the PATIENT PROBE jack Make sure probe plug is fully seated Use only GAYMAR probes or equivalent YSI 400 series probes approved for use with medical devices If in doubt that the correct probe is being used and is operating properly perform a PROBE CHECK test p 17 10 1 2 item 4 o Press the MONITOR mode button The window on the top of the MONITOR button will light The patient s t
10. R FLOW is lit refer to Alerts section pp 17 18 for corrective measures Do not fold blankets body wraps 2 Check that the temperature control is operating by pressing the MANUAL mode button and then adjusting the SET POINT temperature to at least 2 C 3 6 F above the indicated water temperature This should cause the WARMING indicator to light 10 2 2 Blanket Body Wrap Will Not Cool Check to see if water is circulating through the blanket body wrap If there is no circulation the CHECK WATER FLOW alert should light If CHECK WATER FLOW is lit refer to Alerts section pp 17 18 for corrective measures Do not fold blankets body wraps 2 Check that rear and side air vents are not blocked Inlet and exhaust grills should be kept clear and clean to allow air to circulate freely 3 Check that the temperature control is operating by changing the SET POINT temperature to at least 2 C 3 6 F below the indicated water temperature This should cause the COOLING indicator to light 10 2 3 Machine Will Not Turn On Make sure the power cord is plugged in 2 Resetthe ON OFF switch circuit breaker by turning it first off then on 3 Ifthe machine still does not turn on remove machine from service and notify your medical equipment repair department 10 2 4 OnlOff Switch Is Turned On But Control Panel Is Dark And No Operating Sound Is Coming From Machine Remove machine from use and notify your medical equipme
11. T display will indicate the default temperature 32 C 89 6 F at start up until selecting the SET POINT temperature in step 4 below e If desired change the temperature scale by pressing the C F button Adjust the SET POINT display to the prescribed water temperature setting by pressing the V or A button to decrease or increase the SET POINT The STATUS display will indicate WARMING or COOLING while the machine is heating or cooling the water When the water temperature stabilizes within 0 C 1 8 F of the SET POINT temperature both the COOLING and WARMING displays will turn off indicating that the desired water temperature is being maintained NOTE When the Medi Therm lll machine is turned the machine set point defaults to 32 C 89 6 F when MANUAL mode is selected or 37 C 98 6 F when AUTO mode is selected Once a SET POINT temperature for a mode has been selected it is retained for that mode until the SET POINT temperature is changed or the machine has been turned off The SET POINT temperature in one mode does not affect the SET POINT temperature in another mode Medi Therm III Modes of Operation Manual Mode EAGAYMAR e SELECT MODE To control WATER temperature Connect blanket s Press MANUAL button MANUAL Set desired water temperature To control PATIENT temperature Connect blanket s Insert patient probe Press AUTO button Press a
12. devices c If probe appears defective try another probe and repeat PROBE CHECK If a new correct probe does not meet this test remove machine from use and notify your medical equipment repair department 10 1 3 Add Water Check to make sure water is at the proper level by raising the cover on the water fill opening If green band on float is not visible fill with distilled water until the green band is visible fig 7 p 6 If green band on float is visible do not add water remove machine from use and notify your medical equipment repair department A CAUTION Add distilled water only Failure to use distilled water may result in poor machine performance Do not use alcohol Alcohol may accelerate blanket body wrap deterioration Do not operate without water Damage to internal components may result Do not overfill Overfilling may result in overflow because the water in the blanket body wrap drains back into the machine when the machine is turned off 10 1 4 Remove From Use Now Machine Shutdown This alert indicates that the machine has shut down due to a malfunction See Section 6 0 for shutdown procedure Remove machine from use immediately Notify your medical equipment repair department 18 10 2 Troubleshooting 10 2 1 Blanket Body Wrap Will Not Heat l Check that water is circulating through the blanket body wrap If there is no circulation the CHECK WATER FLOW alert should light If CHECK WATE
13. di Therm IIl Hyper Hypothermia machine provides a means of regulating patient temperature by supplying temperature controlled water through a connector hose to a Gaymar Hyper Hypothermia blanket body wrap The companion blanket body wrap provides the interface for heating or cooling the patient A patient probe senses patient temperature The Medi Therm IIl machine Hyper Hypothermia blanket body wrap connector hose and patient probe comprise the Medi Therm IIl system fig 1 Please read and understand the precautions on page and the following operating instructions before attempting to use the Medi Therm Ill system In addition we recommend you request in service training from your Gaymar representative Medi Therm III Features 3 0 Features Please familiarize yourself with the location and purpose of the features fig 2 before reading the start up procedures or attempting to operate the Medi Therm III Machine Water Fill Opening Lift cover Fill unit with distilled water until green band on float is fully visible p 6 Operating Instructions amp Precautions Condensed instructions are located on the cover of the water fill opening and on the rear facing side of the Operator Control Panel s sloped surface Operator Control Panel Identifies displays indicators and controls used in Medi Therm III operation pp 4 5 Patient Probe Jack Accepts patient probe plug connecting patient p
14. e probe to lose flexibility and resistance to cracking Disposable probes should be discarded after use Care of Medi Therm 111 Medi Therm III 9 4 Probe Check Well Care The PROBE CHECK WELL should be cleaned with a small tubular brush and detergent and then wiped with a commercial disinfectant A DANGER When performing the PROBE CHECK use a protective sheath on the probe Becton Dickinson catalog 3700 oral sheath or equivalent Failure to use a sheath could result in cross contamination protective sheath Figure Probe Check Well 9 5 Connector Hose Care The reusable connector hoses should be cleaned with a damp cloth and mild detergent Always wipe dry 9 6 Quick Disconnects The quick disconnects joining the connector hose to the machine may become difficult to engage This problem can be eliminated by applying a silicone base or light machine oil to the outside of the male connector prior to engagement 9 7 Draining Machine It is not necessary to drain the Medi Therm III machine after each use However periodic draining is recommended at least once a month To lower the water level close both pinch clamps on the connector hose Place the end with both Clik Tite connectors into a sink or pail Open the pinch clamps Press the ON OFF switch to ON and press MANUAL mode button The machine will pump the water reservoir empty Press ON OFF button to OFF when CHECK WATER FLOW lights After
15. emperature will be displayed O If desired change the temperature scale by pressing the C F button NOTE If the patient probe senses an abnormal patient temperature below 29 C 84 2 F or above 45 C 113 F the CHECK PATIENT PROBE alert will light and sound an audible alarm This condition may indicate the patient probe has become dislodged an incorrect probe is being used or a probe has become defective see Alerts pp 17 18 REMEMBER in MONITOR mode no therapy is provided Medi Therm III Patient Safety 8 0 Patient Safety A WARNING Use the Medi Therm IIl Hyper Hypothermia machine only under the direction of a physician A physician s order is required for use of equipment Check the integrity of the skin according to department protocol when regulating temperature with external devices Review the following precautions and procedures prior to each application A DANGER Do not use the Medi Therm lIl machine in the presence of flammable anesthetics Risk of explosion can result WARNING If the patient s temperature is not responding does not reach the prescribed temperature in the prescribed time or deviates from the prescribed temperature range notify the attending physician promptly Failure to notify the physician promptly may result in serious injury or death Power interruption will cause the Medi Therm III machine to go into a standby mode resulting in no therapy
16. erapy to the patient Follow instructions for desired mode to resume operation Failure to resume therapy could result in serious injury or death The Medi Therm Ill machine is designed to operate in three 3 modes e MANUAL water temperature control e AUTO automatic patient temperature control and e MONITOR patient temperature monitoring Two gray hose sets are provided to connect multiple blankets and or body wraps in order to provide more body surface contact Increased body surface contact facilitates more efficient warming cooling NOTE When connecting a second blanket body wrap to the Medi Therm IIl machine check the water level see Start up Procedure pp 5 7 prior to connecting the additional blanket body wrap 7 Manual Mode To Control Water Temperature When operating in the MANUAL mode the Medi Therm machine regulates the WATER temperature to the selected SET POINT A temperature sensor within the machine monitors water temperature and the machine heats or cools the water as required to bring it to the SET POINT temperature In MANUAL mode the operator must observe the patient s temperature and manually adjust the water temperature to obtain the desired results To operate in MANUAL mode 1 Perform all start up procedures pp 5 7 o9 Press the MANUAL mode button The window on the top of the MANUAL button will light The WATER display will indicate water temperature The SET POIN
17. f the patient Failure to monitor patient may result in skin damage or inappropriate patient temperature Avoid placing additional heat sources between the patient and blanket body wrap Skin damage may result Prevent excessive and or prolonged tissue pressure and shearing forces especially over boney prominences Skin damage may result continued next column Safety Precautions A WARNING Keep the area between the patient and the blanket body wrap dry Excessive moisture may result in skin damage Do not tip machine over without first draining the water out and unplugging the power cord Damage to the machine or electrical shock can result Repairs should be performed by qualified personnel such as certified biomedical electronics technicians or certified clinical engineers familiar with repair practices for servicing medical devices and in accordance with the Medi Therm Service Manual Do not attempt repairs to Gaymar medical equipment unless you possess these skills Damage to the machine or malfunction may otherwise result All wire lead patient connected transducer assemblies are subject to reading error local heating and possible damage from high intensity sources of RF energy Inadequately grounded electrosurgical equipment represents one such source since capacitively coupled currents may seek alternate paths to ground through probe cables and associated instruments Patient burns may result
18. gain to select CONTROL OPTION Set desired patient temperature CONTROL To monitor PATIENT temperature Insert patient probe fou lt AN Press MONITOR button MONITOR TEST LIGHTS AND ALARM SILENCE ALARM MEDI THERM III at TEMPERATURE ANS Patient Figure 8 Manual Mode A WARNING Check the integrity of the skin according to department protocol when regulating temperature with external devices Frequency of assessment and documentation will vary depending upon the individual response of the patient Failure to monitor patient may result in skin damage or inappropriate patient temperature NOTE While operating in the MANUAL mode the patient probe may be used to monitor the patient s temperature To use this Medi Therm IlI feature insert sensing end of patient probe into patient and tape securely to prevent accidental dislodgment Insert plug end of patient probe into PATIENT PROBE jack Make sure probe plug is fully seated The MANUAL mode switch must be pressed Use only GAYMAR probes or equivalent YSI 400 series probes approved for use with medical devices If in doubt that the correct probe is being used and is operating properly perform a PROBE CHECK test p 17 10 1 2 item 4 Patient temperature will be indicated on the PATIENT temperature display If the patient probe senses an abnormal patient temperature below 29 C 84 2 F or above 45 C 113 F
19. h Clamps Open all pinch clamps on the connector hose and the Hyper Hypothermia blanket body wrap Failure to open the pinch clamps will prevent water flow and will trigger the CHECK WATER FLOW alert 5 4 Check Water Level Check to make sure water is at the proper level by raising the cover on the water fill opening Fill with distilled water until the green band on the float is fully visible fig 7 Figure 7 Float showing proper water level A CAUTION Add distilled water only Failure to use distilled water may result in poor machine performance Do not use alcohol which may accelerate blanket body wrap deterioration Do not operate without water since damage to internal components may result Do not overfill Overfilling may result in overflow because the water in the blanket body wrap drains back into the machine when the machine is turned off Medi Therm III Start up Procedure Shutdown Procedure 5 5 Connect Power Turn Machine On If the machine is not already plugged in insert the power cord plug into a properly grounded AC receptacle at this time Press the ON OFF Switch to the ON position When first turned on the Medi Therm III enters its standby mode the ON OFF switch will light the machine will beep once the SELECT heading will light the WATER PATIENT and SET POINT temperature displays will show dashes and the C or F indicator will light depending on the sca
20. in operation 5 1 Close Pinch Clamps Pinch clamps are provided on both the connector and blanket body wrap hoses to prevent water spillage when blankets body wraps are changed fig 4 Close the pinch clamps on the connector hose and Hyper Hypothermia blanket body wrap Start up Procedure Medi Therm III 5 2 Attach Blanket Body Wrap Attach the Hyper Hypothermia blanket body wrap to the Medi Therm III machine fig 2 a Connect a Gaymar Model DBK9 connector hose to the Medi Therm Ill machine The hose is ten feet long It has quick disconnect metal fittings for the Medi Therm Ill machine end and Clik Tite plastic connectors for the blanket body wrap end To connect the hose attach one quick disconnect fitting to the RETURN machine connection top and one to the SUPPLY bottom See figure 5 To insure a tight connection push the retaining collar toward the cabinet and insert the quick disconnect fitting firmly While holding the fitting allow the retaining collar to snap back into position Check to make sure the fitting is fully engaged by tugging firmly on the hose fitting Return Figure 5 Quick disconnects b Attach the two Clik Tite connectors fig 6 on the connector hose to the blanket body wrap Insert the male fitting into the female When fittings are fully seated snap the locking ring into place to assure a positive lock D Figure 6 Clik Tite Connector 5 3 Open All Pinc
21. le last selected NOTE If the ADD WATER indicator lights add distilled water until the green band on the float is visible 5 6 Perform Indicator Light Test Since machine indicators are essential to proper machine operation you should test the indicator lights each time the machine is placed in operation Perform this test by pressing and holding the TEST LIGHTS button While holding the TEST LIGHTS button down verify the following occurs the right and left halves of the display panel light alternately e the three status legends FLOW OK WARMING and COOLING light the ALERT legend and its four triangular indicators light the three mode legends SELECT heading and three AUTO CONTROL OPTION legends light the three temperature displays WATER PATIENT and SET POINT indicate 888 888 8 and 888 8 respectively the two temperature control legends C and F and the two lines connecting SET POINT to both the WATER and PATIENT display light the audible alarm toggles If any indicator does not light or the alarm does not sound remove the machine from use 5 7 Perform Check Flow Procedure when using two gray hose sets When two gray hose sets are in use the CHECK WATER FLOW alarm will only sound if the flow through both gray hoses is occluded To check the flow through the wraps Disconnect one gray hose set from the machine connection If the flow path is patent the alarm will n
22. m can be silenced for five minutes while diagnosing problem by pressing SILENCE ALARM 2 CHECK PATIENT PROBE alert may sound if machine is placed in MANUAL AUTO or MONITOR mode before patient probe has been inserted in patient since probe will be sensing room temperature Place probe in patient and wait for patient temperature to stabilize before pressing MANUAL AUTO or MONITOR mode button 3 Check probe to make sure it has not become dislodged from patient Reinsert and tape securely if required Wait for patient temperature to stabilize before pressing AUTO mode button 4 Perform PROBE CHECK a Insert probe into protective sheath and then into PROBE CHECK WELL on front of machine base fig 11 16 A WARNING When performing the PROBE CHECK use a protective sheath on the probe Failure to use a sheath could result in cross contamination Alerts Troubleshooting Medi Therm III b Operate machine in MANUAL mode with a blanket body wrap connected Adjust SET POINT temperature to between 33 C 91 4 F and 37 C 98 6 F Wait until machine temperature stabilizes Both the WARMING and COOLING lights are off and patient temperature display stabilizes Water and patient temperature displays should read within 2 C 3 6 F of each other If not patient probe may be defective or incorrect probe is being used Use only GAYMAR probes or equivalent YSI 400 Series probes approved for use with medical
23. n both MANUAL and AUTO modes FLOW OK indicates water is flowing adequately WARMING indicates water is being heated The maximum water temperature is 42 C 107 6 F COOLING indicates water is being cooled Minimum water temperature is 4 C 39 2 F o ALERT SECTION ALERT J indicators light when some form of operator action is required In addition to the visual indicator an audible alarm may sound ALERT controls allow the Medi Therm III operator to test panel lights or to silence the audible alarm W CHECK WATER FLOW indicates the flow of water to the blanket body wrap has been restricted NOTE When two gray hose sets are in use the Check Water Flow alarm will only sound if the flow through BOTH gray hose sets is occluded See page 7 section 5 7 AN CHECK PATIENT PROBE indicates the patient probe is sensing an abnormal patient temperature below 29 C 84 2 F or above 45 C I 13 F It may indicate the patient probe has become dislodged an incorrect probe is being used or a probe has become defective An audible alarm accompanies this alert 9 VJ ADD WATER indicates the water reservoir is filled to less than the recommended level Medi Therm III Start up Procedure REMOVE FROM USE NOW MACHINE SHUTDOWN indicates the Medi Therm III has shut down due to a malfunction An audible alarm accompanies this alert Remove the Medi Therm 111 machine from use immediately Refer to Section 6 0 for shu
24. nt repair department Medi Therm III Blankets Body Wraps I Accessories Training Warranty 11 0 Blankets Body WrapslAccessories All Gaymar products are latex free Adult and pediatric size blankets are available in all vinyl or vinyl with nonwoven fabric surfaces Adult body wraps are available in vinyl with nonwoven fabric surfaces only SINGLE PATIENT USE BLANKETS PLASTIC WITH NONWOVEN FABRIC DHP810 O R Table and General Use 25 x 64 DHP812 Pediatric General Use 22 x 33 DHP813 Adult General Use 30 x 64 SINGLE PATIENT USE BLANKETS ALL VINYL DHP90I Adult General Use 25 x 69 DHP902 Pediatric General Use 25 x 36 REUSABLE BLANKETS HEAVY DUTY VINYL HP7010 Adult General Use 25 x 69 HP7020 Pediatric General Use 25 x 36 SINGLE PATIENT USE TORSO WRAPS POLYMER WITH NONWOVEN FABRIC DHV530 Small Medium DHV535 Large SINGLE PATIENT USE LEG WRAPS POLYMER WITH NONWOVEN FABRIC DHL540 One size fits all All blankets and body wraps require reusable DBK9 connector hoses Products with Colder style connectors are available for the Medi Therm IIl Contact Gaymar customer services for availability ACCESSORIES DBK9 Connector Hose 10 HBX8 Hose Extension 10 PATIOI Adult Reusable Probe YSI 400 series PATIO2 Pediatric Reusable Probe YSI 400 series DP400CE Disposable Probe Adult and Pediatric YSI 400 series ADPIOCE Reusable Probe Adaptor MTA33 Germicide Algaecide 12 0 Cust
25. omer Training In service training is recommended and can be arranged through your Gaymar Representative Comprehensive repair and maintenance training is also available through Gaymar Technical Services for telephone numbers see back cover 13 0 Warranty The Medi Therm IIl Hyper Hypothermia machine is warranted free of defects in material and workmanship for a period of two 2 years under the terms and conditions of the Gaymar warranty in place at the time of purchase The compressor portion of the machine carries a five 5 year prorated warranty Contact Gaymar Technical Service if you have questions about warranty or repair This page intentionally left blank GAYMAR Gaymar Industries Inc 10 Centre Dr Orchard Park New York 14127 2295 Phone 1 800 828 7341 Fax 1 800 993 7890 In Canada Contact Waterloo Bedding Company Ltd 825 Trillium Dr Kitchner Ontario N2R 1J9 Phone 1 800 203 4293 Fax 1 591 742 3699
26. orted to injure the skin when allowed to remain between patients and water circulating heating blankets body wraps during prolonged procedures A CAUTION Place a dry absorbent sheet between the patient and the blanket when using the plastic like side of any blanket Moisture may accumulate which may result in skin damage A dry absorbent sheet placed between the patient and the Hyper Hypothermia Blanket will provide a sanitary barrier and absorb perspiration It will also promote more uniform distribution of heat Vinyl blankets with nonwoven fabric surfaces and body wraps do not require an absorbent sheet when using the nonwoven side Medi Therm III REFERENCES Gendron F G Unexplained Patient Burns Chap 5 p 87 Quest Publishing Co 1988 Scott Stewart M Thermal Blanket Injury in the Operating Room Arch Surg Vol 94 p 181 Feb 1967 Crino Marjanne H Thermal Burns Caused by Warming Blankets in the Operating Room Clinical Workshop Vol 29 pp 149 150 Jan Feb 1980 Gendron Francis G Journal of Clinical Engineering Vol 5 No pp 19 26 January March 1980 Moritz A R and Henriques Jr Studies of Thermal Injury Il In The Relative Importance of Time and Surface Temperature in the Causation of Cutaneous Burns Am J Path 23 695 1947 Stoll Alice M and Chianta Maria A Method and Rating System for Evaluation of Thermal Protection Aerospace Medicine Vol 40 No 11 pp 1232
27. ot sound Reconnect the hose to the machine Disconnect the second gray hose set from the machine connection If the flow path is patent the alarm will not sound Reconnect the hose to the machine See p 6 section 5 2 part a for instructions on properly connecting the hoses to the Medi Therm Ill This completes the start up procedures for the Medi Therm III machine Please proceed to sections 7 0 through 7 3 for the operating instructions for MANUAL AUTO and MONITOR modes 6 0 Shutdown Procedure When therapy is completed turn off the Medi Therm Ill machine Allow water in blanket body wrap to drain back into machine Close pinch clamps before disconnecting the blanket body wrap Modes of Operation Manual Mode Medi Therm III 7 0 Modes of Operation Read and understand the contents of these Operating Instructions and associated precautions before using the Medi Therm III machine Any application of the Hyper Hypothermia System must be under the direction of the attending physician WARNING f the patient s temperature is not responding or does not reach the prescribed temperature in the prescribed time or deviates from the prescribed temperature range notify the attending physician promptly Failure to notify the physician promptly may result in serious injury or death Power interruption will cause the Medi Therm 11 machine to go into a standby mode see item 5 5 p 7 resulting in no th
28. ration of the blanket body wrap To locate and correct the source of low flow NOTE When two gray hose sets are in use the CHECK WATER FLOW alarm will only sound if the flow through BOTH gray hose sets is occluded See p 7 section 5 7 for instructions on checking flow path when two gray hose sets are in use Check that hoses are fully inserted and seated into one RETURN top and one SUPPLY bottom connector on the machine See Start up Procedure p 6 2 Check that all pinch clamps are fully open 3 Check that hoses are not kinked or pinched off Make sure blanket body wrap is not kinked or creased If a blanket body wrap is used with patient in sitting position flow may be pinched off 4 Confirm that water supply is at proper level 5 Turn off machine Close all pinch clamps Disconnect blanket body wrap from connector hose Direct connector hoses into water fill opening start machine and select MANUAL or AUTO mode Open connector pinch clamps If there is still no flow turn machine off and remove from use 10 1 2 Check Patient Probe Indicates that the patient probe is sensing below 29 C 84 2 F or above 45 C 113 F and is not a normal patient temperature A WARNING If CHECK PATIENT PROBE light comes on therapy will stop in AUTO mode only status lights will go out and no additional heating or cooling will occur until the problem is corrected CHECK PATIENT PROBE audible alar
29. robe to machine pp 10 1 2 Use only Gaymar probes or equivilent YSI 400 series probes approved for use with medical devices Dual Blanket Body Wrap Connections amp Probe Check Well Quick disconnects facilitate connection to water supply p 6 PROBE CHECK well verifies patient probe 7 ONIOFF Switch Circuit Breaker Controls power to Medi Therm Figure 2 Medi Therm III features Operator Control Panel Medi Therm III wEAGAYMAR To control WATER temperature Connect blanket s Press MANUAL button Set desired water temperature To control PATIENT temperature Connect blanket s Insert patient probe Press AUTO button Press again to select CONTROL OPTION Set desired patient temperature NO THERAPY AN e Insert patient probe MONITOR TEST LIGHTS AND ALARM SILENCE ALARM P Rapid Moderate Me Gradual To monitor PATIENT temperature Press MONITOR button MEDI THERIM III Patient CONTROL OPTION Set Point Figure 3 Medi Therm III Control Panel 4 0 Operator Control Panel The control panel is divided into sections according to function and use The principal panel sections are identified in figure 3 1 STATUS SECTION STATUS displays light to indicate both the machine s flow status and how the water temperature is being controlled to reach the desired temperature setting STATUS displays function i
30. selected or 37 C 98 6 F when AUTO mode is selected Once a SET POINT temperature for a mode has been selected it is retained for that mode until the SET POINT temperature is changed or the machine has been turned off The SET POINT temperature in one mode does not affect the SET POINT temperature in another mode The unit will heat or cool as required to bring the patient temperature to the SET POINT The STATUS display will indicate WARMING or COOLING while the machine is heating or cooling the patient When the patient temperature stabilizes within 0 5 C 0 9 F of the SET POINT temperature both the COOLING and WARMING displays will turn off indicating that the desired patient temperature is being maintained The rate of cooling and warming is user adjustable through the use of the CONTROL OPTION The CONTROL OPTION defaults to RAPID when AUTO mode is entered Select a different CONTROL OPTION by pressing the AUTO button again When COOLING the patient RAPID the coldest water is used for cooling as low as 4 C 39 F This may not be the most comfortable setting for the patient MODERATE Water temperature is limited to 15 C 27 F below the patient s temperature This will provide an improved comfort setting to the patient GRADUAL Water temperature is limited to 10 C 18 F below the patient s temperature This will provide the optimal comfort setting to the patient e Modes of Operation
31. ssing the AUTO button again closed open Figure 4 Pinch Clamps MONITOR selects the monitor mode of operation In MONITOR mode the operator may monitor patient temperature without providing therapy TEMPERATURE SECTION TEMPERATURE displays identify WATER PATIENT and SET POINT temperatures WATER indicates the actual temperature of the water being delivered to the blanket body wrap This display is illuminated only when MODE is set to MANUAL PATIENT indicates actual patient temperature as sensed by the probe connected to the patient probe jack This display is illuminated when MODE is set to MANUAL AUTO or MONITOR and a patient probe is plugged into the PATIENT PROBE jack SET POINT indicates the desired SET POINT temperature When operating in MANUAL mode pressing the SET POINT button V or A sets the desired water temperature When in AUTO mode pressing the SET POINT button sets the desired patient temperature C F displays the temperature in either degrees Celsius C or Fahrenheit F Pressing the C F button will display the corresponding indicator 5 0 Start up Procedure For your convenience condensed versions of the following instructions have been permanently mounted on the cover of the water fill opening and on the rear facing side of the Operator Control Panel s sloped surface Perform the following start up procedure each time the Medi Therm IIl system is placed
32. tdown procedure Notify your medical equipment repair department TEST LIGHTS confirms that all indicator lights and digital displays are working and that the audible alarm is functioning The displays flash and the audible alarm sounds as long as the TEST LIGHTS button is pressed SILENCE ALARM temporarily silences the audible alarm The alarm will reactivate in approximately 5 minutes if the condition persists NOTE The SILENCE ALARM button will not function if the REMOVE FROM USE NOW MACHINE SHUTDOWN indicator is lit MODE SECTION The SELECT MODE indicator lights when the Medi Therm is in STANDBY MODE MODE buttons select the desired operating mode Patient therapy is provided in either MANUAL or AUTO mode A third mode MONITOR may be used to monitor patient temperature without providing therapy After the mode button is pressed the window at the top of the mode button lights In AUTO mode one of three additional CONTROL OPTION indicators light MANUAL selects the manual mode of operation In MANUAL mode the operator must observe patient temperature and adjust the water set point temperature to obtain the desired results AUTO selects the automatic mode of operation In AUTOMATIC mode the operator sets the desired temperature and the patient temperature is automatically regulated to the operator specified set point Automatic cooling and or warming can be adjusted to RAPID MODERATE or GRADUAL rates by pre
33. the water is pumped out do not leave the machine on or it may overheat Preventive maintenance and service procedures are described the Medi Therm Ill Service Manual These procedures should be performed by qualified personnel such as certified biomedical electronics technicians or certified clinical engineers Medi Therm III Alerts Troubleshooting 10 0 Alerts Troubleshooting Most Medi Therm lll operating problems are minor and can be corrected by the operator The following are alerts and troubleshooting details A WARNING Repairs should be performed by qualified personnel such as certified biomedical electronics technicians or certified clinical engineers familiar with repair practices for servicing medical devices in accordance with the Medi Therm III Service Manual Do not attempt repairs to the Medi Therm III machine unless you possess these skills Damage to the machine malfunction or electrical shock may otherwise result 10 1 Alerts The Medi Therm III machine has both visual and audible alert indicators to help you identify machine or operator caused problems An explanation of these signals and their probable causes follow Perform corrective action in the sequence listed 10 1 1 Check Water Flow Circulation of water through the blanket body wrap has been restricted Air bubbles in the blanket body wrap may remain stationary although water is flowing a few bubbles do not adversely affect ope
34. to the patient Follow instructions for desired mode to resume operation Failure to resume therapy could result in serious injury or death The Medi Therm lll machine is provided with a means of checking rectal esophageal temperature probes When performing the PROBE CHECK p 17 10 1 2 item 4 use a disposable protective sheath on the probe Failure to use a sheath could result in cross contamination continued next column Frequency of assessment and documentation will vary depending upon the individual response of the patient Failure to monitor patient may result in skin damage or inappropriate patient temperature PEDIATRICS The temperatures of infants and children are more responsive to surface heating and cooling than adults The smaller the patient the more pronounced the effect because of their higher ratio of skin contact area to body mass TEMPERATURE SENSITIVE PATIENTS Patients with impaired peripheral blood circulation caused by vascular diseases and patients who are incapacitated may be more sensitive to temperature changes than patients with more normal circulation OPERATING ROOM PATIENTS Patients with poor circulation associated with inadequate heart function reduction in blood volume and constriction of peripheral blood vessels may deviate from the normal response to the external application of heat and cold Avoid placing additional heat sources between the patient and blanket bod
35. y wrap Skin damage can result Heat applied by the blanket body wrap can result in a rise in skin temperature at the areas of contact The additional heat rise due to electrosurgical currents flowing to the dispersive electrode could be sufficient to cause tissue injury Each thermal effect by itself may be completely safe but the additive effect may be injurious Keep additional heat sources from between the patient and the blanket body wrap continued next page Patient Safety WARNING Prevent excessive and or prolonged tissue pressure and shearing forces especially over boney prominences Skin damage may result Localized skin injury due to tissue compressed between boney prominences and fluid filled channels has occurred during prolonged cardiovascular procedures at water temperatures well below the scientifically established epidermal burn injury threshold Local ischemia can follow the application of pressures exceeding capillary pressure resulting in tissue necrosis This local effect may be enhanced by generalized impairment of the circulation local shearing forces and increased metabolic demand because of temperature elevation Pathological changes may begin in two 2 hours Keep the area between the patient and the blanket body wrap dry Excessive moisture may result in skin damage The application of heating or cooling may affect the toxicity of solutions Prep solutions have been rep
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