Page 2
Date Change Approval 4/8/09 Original version 5/4/10 Added disposal procedures for standards compliance 3/21/12 Updated to R2, added MCH-1000(m) information 3/27/14 Added Cardioplegia Shared Channel (CSC) Module information 8/1/14 Updated maintenance procedures 11/4/14 Added Thermo-Electric Cooling (TEC) Module information 6/15/15...
Page 3
CardioQuip is prohibited. Manufacturer’s Responsibility CardioQuip may consider itself responsible for any effect on the safety, reliability and performance of the equipment if and only if: •...
Page CardioQuip Modular Cooler-Heater Operator/Service Manual Table of Contents General Information ....................Introduction ........................Indications for Use ....................... Expected Service Life ....................Warnings and Precautions .................... Manual Conventions ..................... Device Labeling ......................Specifications ........................ Obtaining Service ......................Contact Information .....................
CardioQuip Modular Cooler-Heater Operator/Service Manual General Information Introduction The CardioQuip Modular Cooler-Heater (MCH) brings easy and accurate temperature control to the operating room. The latest touchscreen technology offers fast, user-friendly, multi-language device control. Redundant software and hardware failsafes ensure patient safety. A combination of audible and visual alerts enable effective monitoring without undue distraction.
CardioQuip Modular Cooler-Heater Operator/Service Manual Page 5 Warnings and Precautions WARNING: To avoid the risk of electrical shock, this equipment must only be connected to a supply ➡ mains with protective earth. WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided ➡...
Page CardioQuip Modular Cooler-Heater Operator/Service Manual Manual Conventions This Operator’s Manual uses the international alert symbol ! to indicate critical safety and operational information. The alert symbol followed by a WARNING denotes an instruction or procedure which, if not carried out correctly, may result in injury to the technician, the patient or other personnel.
MCH-1000(i): 26x16x35 in (66x42x89 cm) MCH-1000(m): 19x9x16 in (48x23x42 cm) Weight (empty/full/max) MCH-1000(i): 85 lbs (39 kg) / 165 lbs (75 kg) / 258 lbs (117 kg) MCH-1000(m): 45 lbs (21 kg) / 65 lbs (30 kg) / 76 lbs (34 kg) Water capacity MCH-1000(i): Min 3 gal.
CardioQuip may, at its option, repair the Equipment on site. (2) The Equipment must not have been repaired or altered outside of CardioQuip's factory in any way which, in the judgment of CardioQuip, affects its stability and reliability. The Equipment must not have been subjected to misuse, abuse or accident.
Storage section. Lifting The MCH-1000(i) should be lifted by no fewer than 2 persons, and should be drained prior to being lifted. Use proper lifting techniques to avoid injury. The lift points are located at each of the four corners.
Page CardioQuip Modular Cooler-Heater Operator/Service Manual Overview In order to enjoy the greatest reliability from your MCH, please familiarize yourself with the essential parts and basic function of the device. MCH-1000(i) Hardware Overview Control Unit Cold Water Tank Cover Control Unit Clamp...
CardioQuip Modular Cooler-Heater Operator/Service Manual Page 11 MCH-1000(m) Hardware Overview Cold Water Tank Lid Lid Anchor Knob Control Screen Mains Power Switch Main Hose Connectors System Drain Connector Mains Power Cord Operation Overview The MCH operating software serves two basic functions. First, it provides an intuitive, feature- rich touchscreen control interface, giving the operator quick access to temperature settings, pump speed control, system test and status information, and customization features.
CardioQuip Modular Cooler-Heater Operator/Service Manual Control Screens Power-on When the Mains Power Switch is first turned on, the CardioQuip logo will appear on the Control Unit screen along with the text, “Initializing...” to indicate that the MCH is booting. After approximately five seconds, the MCH will enter operational mode.
CardioQuip Modular Cooler-Heater Operator/Service Manual Page 13 System Test On startup, the MCH enters TESTING mode and runs a system test to verify proper operation of all internal components. Onscreen indicator lamps display the status of control and feedback signals for the various internal systems, and the “Test Status” column (far right) displays the test results.
Page CardioQuip Modular Cooler-Heater Operator/Service Manual Standby In STANDBY mode, the pump and heaters are off, and the operator is able to preset the desired temperature and other settings in preparation for entering RUN mode. System mode indicator Customizable text...
CardioQuip Modular Cooler-Heater Operator/Service Manual Page 15 Priming From the STANDBY screen, touch the “Prime” button to enter PRIMING mode. While the MCH is designed to be largely self-priming, running a priming cycle will remove all air bubbles from the lines, offering quieter operation and better heat transfer. During the priming cycle, the pump runs at high speed, and the cooling control valve automatically alternates the water flow between cooling mode and recirculating mode every ten seconds.
Maintenance info button (when heating) Defrost button System Time: Displays the number of hours and minutes the MCH-1000 has been in operation. Current Mode: Allows the operator to reduce the electrical current draw (e.g., when running on battery or generator power). In “Normal” mode, the full 1600W of heat is enabled.
CardioQuip Modular Cooler-Heater Operator/Service Manual Page 17 Defrost The MCH incorporates a built-in defrost cycle, which utilizes the heaters in a special recirculating mode to melt the ice in the cold water tank. Once the water in the tank reaches room temperature, the MCH automatically returns to STANDBY mode.
Page CardioQuip Modular Cooler-Heater Operator/Service Manual The CPG Module controls are only visible if the Cardioplegia Shared Channel (CSC) Module is installed, and offer the following operational modes: Water does not flow through the CPG circuit. Water is circulated directly from the MCH cold water tank through the CPG circuit by a secondary water pump.
CardioQuip Modular Cooler-Heater Operator/Service Manual Page 19 Low Ice (low priority) If the MCH is unable to cool to the set temperature within 40 seconds due to insufficient cold water in the tank, the Low Ice alarm sounds a short double- beep alarm every 20 seconds.
If the FAILURE screen appears repeatedly, this may indicate a serious problem with your MCH unit that could affect patient and operator safety. Even if the system returns to normal operation after a system test or a power cycle, please contact CardioQuip for troubleshooting assistance and, if necessary, to schedule a service call.
CardioQuip Modular Cooler-Heater Operator/Service Manual Page 21 Setting the Temperature Touching the dark blue “Set Point” temperature field will cause a numeric keypad to appear onscreen, allowing direct input of the desired temperature. After entering the desired temperature, touch the “ENT”...
OUT connector and recirculated into the system at the IN connector. Water at the OUT connector is under pressure when the system pump is on. These connectors are oriented horizontally on the MCH-1000(i), and vertically on the MCH-1000(m).
OUT connector and recirculated into the system at the IN connector. Water flow is controlled by the CPG controls on the touchscreen. These connectors are oriented horizontally on the side of the MCH-1000(i). Internal Recirculation Valve The internal recirculation valve is located on the rear...
Page CardioQuip Modular Cooler-Heater Operator/Service Manual Blanket Hose Connectors The smaller connectors on the MCH-1000(i), directly below the “Main” connections on the rear panel of the MCH, are for connections to patient warming blankets. Maximum water flow at the blanket connectors is approximately 4 liters/min (1.0 gal/min).
MCH-1000(i). Tank Drain The tank drain valve is located on the front panel of the MCH-1000(i), and allows the operator to drain water from the cold water tank without draining the entire system. This may be useful e.g. to make room in the tank for more ice during a procedure. To open the valve, turn the valve lever so that it is parallel with the valve body.
PVC tubing, ball valves and a short section of flexible clear tubing at the oxygenator end. Standard lengths are 10ft (3m) for the MCH-1000(i) and 6ft (1.8m) for the MCH-1000(m). Dripless Anti-Microbial Hose Kit...
Any patient blanket used with the MCH must meet IEC 80601-2-35 standards for heating devices. CardioQuip has specifically tested the MCH with the Cincinnati Sub-Zero PlastiPad™ Reusable Plastic Blanket and Maxi-Therm™ Single Patient Use Blanket, and the Adroit Soft- Temp™...
Page 30
WARNING: Do not use a patient blanket to heat a patient with an ischemic limb. This can result in burn injuries to the patient. For most applications, CardioQuip recommends that the patient blanket be laid flat, without creases or wrinkles, between the bed or table and the patient, according to the diagram below.
CAUTION: Do not plug the TEC Module into the same electrical circuit as the MCH-1000(m). The TEC Module draws approximately 1.5 Amps of power, so it may be able to share a circuit with other equipment. The MCH-1000(m) requires a separate dedicated 20 Amp circuit (see Initial Operation Check).
1.5 hours. Installation Remove the factory tank lid from the MCH-1000(i). Team-lift the Refrigeration Module from its shipping crate per the Lifting instructions, and set it in place on top of the MCH tank. Always keep the Refrigeration Module upright.
Page 33
CAUTION: Do not plug the Refrigeration Module into the same electrical circuit as the MCH-1000(i). The Refrigeration Module draws approximately 1.5 Amps of power, so it may be able to share a circuit with other equipment. The MCH-1000(i) requires a separate dedicated 20 Amp circuit (see Initial Operation Check).
Prior to operation in a clinical setting for the first time, or after extended storage, the following procedures should be performed. Contact CardioQuip if any failures are encountered. WARNING: It is the operator’s responsibility to use, check, and maintain this device according to the labels of the product, accompanying instruction manuals, and any revisions of the labeling or instructions that may be subsequently issued.
CardioQuip Modular Cooler-Heater Operator/Service Manual Page 33 WARNING: Proper surgical procedures and techniques are the responsibility of the operator. WARNING: To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth.
INTERNAL position and add approximately three gallons (12 liters) of water to the ice tank. MCH-1000(m): Connect a loopback hose to the main hose connectors, and add approximately one gallon (4 liters) of water to the ice tank.
CardioQuip Modular Cooler-Heater Operator/Service Manual Page 35 2. Touch the “silence alarm” button. The audible alarm should silence for approximately 60 seconds, and the OVERTEMP screen should remain. 3. Touch and hold the cold water control button. The system should change to Low pump speed and water should flow into the cold water tank.
CAUTION: Do not overtighten the control panel clamp or articulated arm lock on the MCH-1000(i). Mechanical damage may result. CAUTION: Check for mechanical damage to any heat exchanger, blanket, or other applied part, prior to connecting it to the MCH.
Page 39
The amount of ice needed to perform a given procedure is an operator decision; however, it is recommended that each procedure be started with a full supply (approximately 35 lbs. / 16 kg) of ice in the cold water tank. Note: The MCH-1000(m) holds significantly less ice than the MCH-1000(i).
Page CardioQuip Modular Cooler-Heater Operator/Service Manual High Temperature Alarm WARNING: If the unit is in an overtemp condition and the emergency cool system is used, it is critical that the operator monitor the output water temperature. If the output water temperature exceeds 42.5°C, the MCH will enter overtemp mode. The system pump will stop, the OVERTEMP screen will appear, and an audible alarm will sound.
CardioQuip Modular Cooler-Heater Operator/Service Manual Page 39 Maintenance Water Quality The water in a cooler-heater can harbor various microorganisms commonly found in the hospital environment, some of which can pose serious health risks for immunocompromised individuals. The only effective way to control these risks is to closely monitor the water quality in the cooler- heater, keep it as clean as possible, and treat it like any other biohazardous material.
6. Add the selected cleaning chemical to the cold water tank at the manufacturer’s recommended rates (see chart above for recommendations). Once primed, and with six inches of water in the tank, the MCH-1000(i) contains approximately three gallons (12 liters) of water, and the MCH-1000(m) contains approximately 1 gallon (4 liters) of...
The MCH should receive a complete preventive maintenance service check by an authorized CardioQuip service technician every 12 months. The Annual Preventive Maintenance Checklist at the end of this manual may be used by qualified biomedical personnel to verify essential performance and safety of the MCH.
Page CardioQuip Modular Cooler-Heater Operator/Service Manual Troubleshooting Symptom Possible Cause Solution MCH will not turn on Unplugged Plug into a dedicated “hospital grade” 20A receptacle. No electric power at receptacle Contact hospital maintenance personnel to check electrical outlets and power source.
Page 45
LIM is not rated for the power Contact the LIM vendor. (LIM) alarm or error requirements and/or power factor of the MCH. Excessive leakage current from the Contact CardioQuip Service. If the above table does not address the problem, please contact CardioQuip for assistance.
Page CardioQuip Modular Cooler-Heater Operator/Service Manual Annual Preventive Maintenance Checklist MCH Serial No.: _________________________ Hospital I.D. No.: __________________________ Operator’s Physical Inspection ❑ Completed 1. Power Cord has no cuts or exposed wire and plug has no bent or missing pins.