Ohio Care Plus Series 1000/2000 Incubator. Operation and Maintenance Manual

Transcription

1 Ohio Care Plus Series 1000/2000 Incubator Operation and Maintenance Manual

2 Table User Responsibility of Contents This Product will perform in conformity with the description thereof contained in this operating manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This Product must be checked periodically. A defective Product should not be used. Parts that are broken, missing, plainly worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary, Ohmeda recommends that a telephone or written request for service advice be made to the nearest Ohmeda Regional Service Center. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by Ohmeda and by Ohmeda trained personnel. The Product must not be altered without the prior written approval. The user of this Product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Ohmeda. Caution U.S. Federal and Canadian law restrict this device to sale by or on the order of a licensed medical practitioner ii ii

3 Table of Contents General Precautions Warnings... iii Cautions... iii 1/Introduction Introducing the Ohio Care Plus Incubator /Getting Started 3/General Information Mounting the Care Plus on the cabinet Operating modes The air control (manual) mode The optional patient control mode Controls and displays Alarms Cable connections and mechanical controls /Preoperative Checkout Procedure 5/Using the Incubator Mechanical checks Accessory checks Controller checks Operational checks Basic operating procedure Responding to alarms Air circulation alarm Control temperature alarm High air temperature alarm Patient temperature alarm (Patient control models only) Probe failure alarm (Patient control models only) Power failure alarm System failure alarm Additional operating procedures Accessing the patient Raising and lowering the hood Trendelenburg and reverse Trendelenburg positioning-tilt handle models Administering oxygen Using the optional humidifier ii ii

4 Table of Contents 6/Maintaining the Incubator 7/Service Procedures 8/Illustrated Parts Cleaning schedule Disassembling the incubator for a complete cleaning Cleaning and disinfecting individual components Humidifier Patient Probe Controller assembly Porthole Compartment Temperature Probe Other Clear Plastic Parts Lower unit (mattress, mattress tray, base platform cover, etc.) Oxygen inlet Cabinet Repair Policy Maintenance schedule Operator maintenance Service maintenance Troubleshooting incubator problems Base platform and cover assembly Appendix Care Plus specifications... 1 Electrical specifications... 1 Performance specifications... 2 Safety specifications... 4 Environmental specifications... 4 Electromagnetic Compatibility (EMC) Specifications... 4 Mechanical specifications... 5 Additional Safety Information... 6 Glossary... 7 Warranty iii iii

5 Table General of Precautions Contents Warnings Before using the Ohio Care Plus Incubator, read through this entire manual. As with all medical equipment, attempting to use this device without a thorough understanding of its operation may result in patient or user injury. This device should only be operated by personnel trained in its operation under the direction of qualified medical personnel familiar with the risks and benefits of this type of device. Additional precautions specific to certain procedures are found in the text of this manual. Complete the Pre-operative Checkout Procedures section of this manual before putting the unit into operation. If the incubator fails any portion of the checkout procedure it must be removed from use and repaired. Do not use the Care Plus in the presence of flammable anesthetics; an explosion hazard exists under these conditions. Always disconnect the power before performing service or maintenance procedures detailed in this manual. Apply power only if you are specifically instructed to do so as part of the procedure. Thoroughly air dry the incubator after cleaning it with flammable agents. Small amounts of flammable agents, such as ether, alcohol or similar cleaning solvents left in the incubator can cause a fire. Cautions Only competent individuals trained in the repair of this equipment should attempt to service it as detailed in the Service Manual (Stock Number ). Detailed information for more extensive repairs is included in the service manual solely for the convenience of users having proper knowledge, tools and test equipment, and for service representatives trained by Ohmeda. This Product will perform in conformity with the description thereof contained in this operating manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This Product must be checked periodically. A defective Product should not be used. Parts that are broken, missing, plainly worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary, Ohmeda recommends that a telephone or written request for service advice be made to the nearest Ohmeda Regional Service Center. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by Ohmeda and by Ohmeda trained personnel. The Product must not be altered without the prior written approval. The user of this Product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Ohmeda.. iv iv

6 Table Notesof Contents v v

7 1/Introduction In this section Introducing the Ohio Care Plus Incubator How to use this manual Introducing the Ohio Care Plus Incubator Thank you for selecting the Ohio Care Plus Incubator. The Care Plus adapts to your patient s needs with: manual and optional patient operating modes; an optional passive humidifier; an oxygen inlet; removable inner wall; and zero or ten degree bed positions. From its comprehensive series of alarms and quiet operation, to unique oval portholes for greater lateral access, the Care Plus offers both security and convenience. Its familiar styling integrates into the existing nursery environment. Ohio Care Plus Incubator is a registered trademark of Ohmeda. CI Figure 1-1 The Ohio Care Plus Incubator

8 1/Introduction Care Plus technology The Care Plus combines microprocessor technology, a unique hood design with front to back air flow, and an optional humidifier to stabilize patient temperature: The microprocessor responds immediately to temperature changes, minimizing the temperature fluctuations of older, analog incubators. Heated air circulated along the hood wall, or between the optional double walled hood, warms the surfaces surrounding the infant, reducing radiant heat loss. Limiting air movement around the infant reduces convective and evaporative heat loss. Humidifying the air further reduces evaporative heat loss. WARNING Before using the Ohio Care Plus Incubator, read through this entire manual. As with all medical equipment, attempting to use this device without a thorough understanding of its operation may result in patient or user injury. What warnings and cautions mean No matter what part of this manual you are using, you should always be familiar with the cautions and warnings that appear throughout this manual. Warningsalert you to conditions and actions that can cause injury. Cautions point out conditions or actions that may damage the incubator. Please also take a moment to review the User Responsibility Statement on the inside of the front cover; it describes what is expected of you to maintain the Care Plus Incubator. Also read the Warranty on the back cover; it outlines Ohmeda s responsibility in case of a functional defect. Symbols used in this manual An attention symbol in the left hand column alerts you to a warning or a caution in the text. The attention symbol looks like this: Just as on the controller panel, we use arrow heads to represent the temperature switches: M Increase the control temperature? Decrease the control temperature

9 2/Getting Started WARNINGS Safely mounting or dismounting the Care Plus Incubator requires two people. Remove the controller unit before mounting or dismounting the incubator. Do not place the incubator in direct light. Exposing the infant or the incubator to direct radiation from the sun or incandescent lighting may cause the infant to overheat. Items not covered in this chapter If your system uses any accessories or external monitoring devices (phototherapy light, blender, etc.), follow the mounting instructions in the operation and maintenance manual for the device. In this section Mounting the Care Plus on the cabinet

10 2/Getting Started Mounting the Care Plus on the cabinet WARNING: Safely mounting or dismounting the Care Plus Incubator requires two people. 1. Install the four mounting knobs. WARNING CAUTION If mounting hardware is not securely fastened, the incubator could tip off the stand. When handling the controller, avoid bumping the fan or the heater. If these items are knocked out of alignment, the fan can grate against the heater or the base. 2. Install the controller. Lift the levers on the controller and slide it into the incubator as shown in Figure 2-2. Push the levers down to lock the controller in place. 3. Refer to section 4 in this manual to perform preoperative checkout procedures. Controller CI Controller Lever Mounting Knob Figure 2-1 Mounting the Care Plus Incubator

11 3/General Information In this section Operating modes Operating modes The air control (manual) mode The patient control (servo) mode Controls and displays Alarms Cable connections and mechanical controls The Care Plus has two operating modes: the air control (or manual) mode, which adjusts heater output to achieve a target air temperature; and the patient control (or servo) mode, which adjusts the incubator temperature to achieve a target infant skin temperature. In both modes, the target temperature appears in the Control Temperature display on the front of the controller and can be adjusted using the temperature switches (? and M). To distinguish between control temperatures in the different modes, this manual uses the term air control temperature for the control temperature in the air control mode and the term patient control temperature for the control temperature in the patient control mode. Note: This section briefly mentions displays, controls, and alarms that play a significant role in the air control and patient control modes. For further information, refer to the appropriate section Controls and displays or Alarms. The air control (manual) mode The air control mode compares the air temperature to the air control temperature to determine if the heater should be switched on or off. If the air temperature is too high, the heater switches off. If the air temperature is too low, the heater switches on. Air control temperature The air control mode lets you enter air control range temperatures from 20 to 37 C (68.0 to 98.6 F) using the temperature switches (? and M). Pressing the Override switch when the air control temperature is 37 C (98.6 F) lets you increase the air control temperature to 39.0 C (102.2 F). Control temperature alarm The control temperature alarm triggers if the air temperature exceeds a normal range air control temperature by more than 1.5 C (2.7 F) or if the air temperature falls more than 3.0 C (5.4 F) below the air control temperature. For air control temperatures above 37 C, the control temperature alarm triggers if the air temperature exceeds the air control temperature by more than 1.0 C (1.8 F). To avoid unnecessary alarms, the control temperature alarm does not trigger during the first 30 minutes after power is switched on and for 15 minutes after you change the air control temperature or enter the air control mode from the patient control mode. During this period, normal incubator alarm routines verify proper operation and switch off the heater if the air temperature exceeds certain default safety limits: 38 C (100.4 F) for control temperatures below 37 C (98.6 F) and 40 C (104.0 F) for control temperatures above 37 C

12 3/General Information Patient probe (Care Plus 2000 only) In the air control mode, the patient probe has no affect on incubator operation; connecting the probe simply displays the patient temperature for your information. The patient control mode (Care Plus 2000 only) In the patient control mode, the control temperature (patient control temperature) corresponds to the desired patient skin temperature. To reach an incubator temperature that will maintain the desired skin temperature the incubator control system loops through the program shown in Figure 3-1. This program compares the patient control temperature setting to the actual patient temperature and raises or lowers the incubator temperature depending on whether the infant is hot or cold. The incubator temperature that maintains the desired skin temperature is referred to as the DET (Desired Environmental Temperature). The maximum DET that the incubator will maintain is 39.0 C (102.2 F). You can reduce the time required to reach the DET by preheating the incubator in the air control mode before entering the patient control mode. The closer the air temperature gets to the actual air temperature required to maintain the desired infant skin temperature, the sooner the incubator will stabilize the infant s temperature in the patient control mode. When you switch to the patient control mode, the previous air control temperature becomes the initial DET. The incubator automatically adjusts the DET using the three stage patient control mode program, shown in Figure 3-1. The first stage of the loop checks to make sure that the patient probe is reporting a reasonable patient temperature before making any adjustments. If the patient temperature is less than 30 C (86.0 F) or above 42 C (107.6 F), the incubator assumes that the patient probe has detached from the infant, the patient temperature alarm triggers, the heater shuts off, and the DET remains unchanged. The second stage of the loop calculates the PTG (Patient Temperature Gradient), the difference between the actual patient temperature and the selected patient control temperature, to determine if the infant is hot or cold. If the infant is too cold (PTG < -0.5 C), the heater switches On. If the infant is too hot (PTG > 0.5 C), the heater shuts down. The patient temperature continues to be checked every three seconds. The third stage calculates the change in the patient temperature over the previous ten minute period. If the infant temperature differs from the patient control temperature setting by 0.2 C or more, and this difference has not decreased by at least 0.2 C during the last ten minute period, the DET will be adjusted. To prevent large incubator temperature swings and to allow time for the patient to respond to changes in the incubator temperature, the magnitude of the change in the DET depends on the PTG. Patient control temperature range The patient control mode lets you enter air control temperatures from 35.0 to 37.0 C (95.0 to 98.6 F) using the temperature switches (? and M). An internal adjustment lets you increase the patient control temperature to 37.5 C (99.5 F). Patient temperature alarm Patient temperature alarm monitoring runs concurrently with the control loop. A patient temperature alarm triggers if the patient temperature differs from the patient control temperature by more than 1.0 C (1.8 F), or 0.5 C (0.9 F) with an internal adjustment. Additional alarm routines verify proper operation and switch off the heater if the air temperature exceeds 40.0 C (104.0 F)

13 3/General Information Start Repeat first stage No PT = Patient Temperature PCT = Patient Control Temperat PTG = PT-PCT DPT = Current PT - PT 10 min. previous Is the PT <30 C? Yes Assume probe is dislodged 1) Switch heater off 2) Activate alarm 3) Keep DET constant Have 10 min passed? Yes Start third stage Stage 3 Stage 1 No Is the PT >42 C? Yes Assume probe is dislodged No Infant is cold Is the PTG³0 C? Yes Infant is hot No Is the DPT³ 0.2 C? Yes DET change = 0 Yes Is the DPT -0.2 C? Stage 2 Is the PTG <-0.5 C? No Yes Infant is cold Supply maximum heat No PTG -0.5 C -0.4 C -0.3 C -0.2 C -0.1 C -0.0 C DET Change 0.3 C 0.3 C 0.2 C 0.1 C 0.0 C 0.0 C No PTG 0.5 C 0.4 C 0.3 C 0.2 C 0.1 C 0.0 C DE Chang -0.3 C -0.3 C -0.2 C -0.1 C -0.0 C -0.0 C Is the PTG > 0.5 C? Yes Infant is hot Supply no heat No Calculate new DET New DET = Old DET + Change CI Figure 3-1 Patient control mode logic diagram

14 3/General Information Controls and displays CI Care Plus 1000 CI Care Plus 2000 Figure 3-2 Controls and displays Patient temperature During normal operation, the patient temperature display shows the temperature sensed at the patient probe tip, in Celsius or Fahrenheit. The patient probe must be properly connected to the incubator and the infant for an accurate patient temperature measurement. Temperatures between 22.0 and 42.0 C (71.6 and F) are displayed to the nearest 0.1 C or F. Temperatures above this range result in a HHHH temperature display. Temperatures below this range cause LLLL to be displayed. Depressing the Enable switch for more than five seconds tests the temperature monitoring system. If the monitoring system is functioning correctly, C ±0.2 C replaces the patient temperature during the test. Air temperature During normal operation, the air temperature display shows the internal incubator temperature. Air temperatures between 5 and 50.0 C (41 and 122 F) are displayed to the nearest 0.1 C or F. Depressing the Enable switch for more than five seconds tests the temperature monitoring system. If the monitoring system is functioning correctly, C ±0.2 C replaces the air temperature during the test

15 3/General Information Control temperature During normal operation, the control temperature display shows the control temperature (air or patient) selected by the operator. When you first power up the unit or if you enter the patient control mode, the control temperature flashes and a prompt tone sounds until you enter a control temperature. In the air control mode, the control temperature range is 20 to 39.0 C (68 to F). Air control temperatures above 37.0 C (98.6 F) require the use of the Override switch. In the patient control mode, the control temperature range is 35 to 37 C (95.0 to 98.6 F). Note: Qualified service personnel can configure maximum patient temperature to 37.5 C. During a system failure alarm, the appropriate error code appears in the control temperature display. Depressing the Enable switch for more than five seconds replaces the control temperature with the percentage of the rated line voltage supplied by the power outlet. 100% 75% 50% 25% Four LED displays illuminate to show the average heater power over the last minute as a percentage of the maximum output (100%, 75%, 50% and 25%). In the example, the average heater power is 75% of the maximum power. The alarm silence switch has two functions. Pressing the switch silences all audible alarms except for the system failure and power failure alarms. The length of the alarm silence period depends on the alarm condition as detailed in the Alarms section. The alarm silence indicators (next to the switch) illuminates for the duration of the alarm silence period. Depressing alarm silence switch for five seconds or longer illuminates all control panel LEDs and causes to appear in the temperature displays. The alternating, two tone alarm also activates. The F/ C switch changes the temperature displays from degrees Celsius to degrees Fahrenheit and vice versa. F / Pressing the Enable switch activates the temperature switches (? and M), the mode switches, and the Override switch for approximately 12 seconds. The enable indicator illuminates when these switches are active. If the indicator goes out, you must press the Enable switch again to reactivate these switches. Pressing the Air Control switch selects the air control mode of operation and illuminates the Air Control indicator (next to Control Temperature display). To prevent accidental mode changes, you must press the Enable switch to activate the Air Control switch. The audible alarm sounds briefly when the mode of operation is changed. Note: The incubator defaults to the air control mode when power is first applied

16 3/General Information >37 C The Override switch lets you select air control temperatures higher than 37.0 C (98.6 F). To raise the air control temperature above 37 C, increase the control temperature to 37 C, press the Enable switch, press the Override switch, and then increase the air control temperature. The maximum set temperature is 39 C. The override indicator remains illuminated to indicate that the air control temperature exceeds 37.0 C. Pressing the Patient Control switch selects the Patient control mode of operation and illuminates the Patient Control indicator (next to Control Temperature display). To prevent accidental mode changes, you must press the Enable switch to activate the Patient Control switch. The audible alarm sounds briefly when the mode of operation is changed. The first time that you select the patient control mode, the control temperature display also flashes and an operator prompt tone sounds until you enter a control temperature. These switches adjust the control temperature. To prevent accidental changes, you must press the Enable switch to activate these switches. These switches remain active as long as the enable indicator is illuminated, approximately 12 seconds after the last switch is pressed. The power switch is located on the right side of the controller assembly, adjacent to the power cord socket. It switches the incubator power On and Off. Two circuit breakers, located within the controller, limit the maximum current drawn by the incubator. If the circuit breaker trips, remove the unit from use and contact qualified service personnel for repair. Alarms Note: All silenceable alarms are preceded by a 30 second operator prompt tone. Seven LEDs on the left side of the control panel illuminate for various alarm conditions. Each visual indicator is accompanied by an audio signal. Alarm Patient Temp Air Circulation Probe Failure Control Temp High Air Temp System Failure Power Failure CI Figure 3-3 Alarm indicators

17 3/General Information What the audible tone tells you about the alarm The audio tone varies with the alarm s priority: power failure and system failure alarms cannot be silenced; an alternating two tone alarm indicates a critical alarm that triggers automatic heater shutdown; an intermittent single tone alarm is used for all other alarms. Silencing an alarm With the exception of the power and system failure alarms, all audio alarms can be silenced by pressing the Alarm Silence switch. At the end of the silence period, the audio alarm reactivates unless the alarm condition has been resolved. The alarm silence period ends prematurely if another alarm triggers. When two or more alarms trigger, their respective indicators illuminate, and the audio signal sounds for the highest priority alarm. Patient temperature alarm (Care Plus 2000 only) The patient temperature alarm is only active in the patient control mode of operation. The alarm activates when the difference between the patient temperature and the control temperature is greater than 1.0 C (1.8 F) and resets when the patient temperature returns to within 0.8 C (1.4 F) of the control temperature. Patient probe readings above 42.0 C or below 30.0 C trigger an alternating two tone alarm and automatic heater shutdown. Note: Service personnel can configure the alarm to trigger if the difference exceeds 0.5 C and to reset when the difference is less than 0.3 C. Control temperature alarm The control temperature alarm is only active in the air control mode. The alarm triggers when the air temperature exceeds the control temperature by more than 1.5 C, (2.7 F) or falls more than 3.0 C (5.4 F) below the control temperature. This alarm is inactive for 30 minutes after the incubator is first switched on. It is also inactive for 15 minutes after either a mode or control temperature change. High air temperature alarm The high air temperature alarm warns of abnormally high incubator air temperatures and automatically switches Off the heater. This alarm is produced by a circuit that is independent of microprocessor temperature monitoring. The high temperature alarm is not self resetting. After the alarm has been activated, it must be manually reset even if the alarm condition has been resolved. The alarm activation temperature varies with the mode of operation: Mode Control Temperature Alarm Limit Patient Control All Settings 40.0 C (104.0 F) Air Control 20.0 to 37.0 C 38.0 C (100.0 F) 37.0 to 39.0 C 40.0 C (104.0 F) Air circulation alarm The air circulation alarm triggers when air flow inside the unit ceases or is restricted. This could be caused by a blower motor failure, or a missing fan. When this alarm occurs, the heater is automatically shut down

18 3/General Information Probe failure alarm In either operational mode, a disconnected air temperature sensor triggers the probe failure alarm. In the patient control mode, the probe failure alarm can also be caused by an open or a short circuit in the patient probe. When a probe failure alarm triggers, the heater automatically shuts down. The temperature displays indicate the cause of the alarm; if the air temperature sensor is disconnected, the air temperature display flashes 00.0; if the patient probe is disconnected or malfunctioning, the patient temperature display flashes HHHH or LLLL respectively. System failure alarm The system failure alarm automatically shuts off the heater and triggers an alternating two tone alarm if an electrical failure is detected. This alarm cannot be silenced. An error code may replace the control temperature to give specific information on the nature of the failure. Power failure alarm A battery operated power failure alarm activates when the external power source fails or is accidentally disconnected. The battery powers the nonsilenceable audible alarm and the microprocessor for up to 10 minutes during a power failure. If power is restored within 10 minutes, the previous mode of operation and control temperatures are recalled

19 3/General Information Audio Alarm Heater Alarm* Signal Mode Possible Causes Silence Status Probe Failure Alternating All Disconnected air 1 min. Off two tone temperature sensor Alternating Pat. Patient probe disconnected, 1 min. Off two tone open or shorted (patient control mode) Control Intermittent Air Air temperature is 1.5 C 15 Temperature single tone above or 3.0 C below control temperature System Alternating All Electrical malfunction or Cannot Off Failure two tone excessive EMI^ in the silence hospital environment. Note the error code and switch the power off. Wait ten seconds and switch the unit back on. If the system failure reoccurs, remove the incubator from use. Air Circulation Alternating All See the Troubleshooting 5 min. Off Failure two tone section in Chapter 7. Patient Intermittent Pat. The difference between the 15 Temperature single tone patient temperature and the (Care Plus control temperature exceeds 2000 only) 1.0 C & Intermittent Pat. The difference between the 5 single tone patient temperature and the control temperatures exceeds 2.0 C Alternating Pat. Patient temperature is above 1 min. Off two tone 42.0 C or below 30.0 C High Air Alternating All In the air control mode without 5 min. Off Temperature two tone override: the air temperature exceeds 38.0 C In the patient control or the air control mode with override: the air temperature exceeds 40.0 C Power Failure Intermittent All Power outage while the power Cannot Off single tone switch is on. silence * If a nonsilenceable alarm is present with no alarm indicator illuminated and the heater is shut down, a microprocessor failure may have occurred. ^ Electro Magnetic Interference from other electrical Heater output is dependent on the patient temperature and the control temperature setting, in the patient control mode and on the control temperature setting in the air control mode. Output will also vary with the ambient room temperature, patient condition, etc. & Service personnel can adjust patient alarm to trigger if the difference exceeds 0.5 C. All silenceable alarms are preceded by a 30 second operator prompt tone

20 3/General Information Cable connections and mechanical controls Portholes Air Temp. Sensor Front Door Latch Tilt Handle MAX 1000 ml MIN CI Figure 3-4 The front of the incubator

21 3/General Information Iris Port Holes Tubing Access Covers Filter Mounting Knobs (Cord Wrap) Humidifier Fill Tray (optional) Controller Latches Patient Probe Connector (Model 2000 only) CI Air Temperature Sensor Connector Figure 3-5 The left side of the incubator

22 Ohmeda Columbia MD Made in USA U.S. Pat. No. 4,936,824 3/General Information Hood Tilt Release W WARNINGS: Fire hazard. Keep matches, lighted Power cigarettes must be disconnected prior to removing bed platform. Oxygen Concentration Chart and all other sources of ignition out of the Air room Heater in which may be thehot. incubator is located. Textiles, oils, and other combustibles are Average oxygen easily ignited and burn with great intensity The in front air enriched door inner with wall must be in place while Oxygen a patient input concentration range oxygen. occupies the incubator. Possible explosion hazard. Do not use in the Use presence only Ohmeda of skin temperature probe. 5L/min 25-45% flammable anesthetics. The humidity reservoir, or humidity reservoir plugs, 10L/min must be 35-55% Oxygen concentrations higher than 40% can increase fully inserted the risk for correct incubator operation, even 15L/min if the 45-75% of retrolental fibroplasia. It is possible that humidifier even concentrations feature is not used. of 40% or less (formerly considered safe) could Use only be dangerous hospital grade grounded power receptacle. NOTE: Oxygen concentration levels in this for some infants. Therefore, arterial blood W gas CAUTION: measurements U.S. Federal and Canadian law restrcts chart thisare intended as a reference only. are extremely important for regulation of the device concentration to sale by ofor on the order of a licensed medical inspired oxygen when in an oxygen enriched environment. Actual concentrations should be checked practitioner. with an oxygen analyzer. m Replace filter every three (3) months.? Oxygen Inlet: Ensure the Controller is sealed and latched prior to administering oxygen.? Power Switch Oxygen Inlet Oxygen Inlet Power Input CI Figure 3-6 The right side of the incubator

23 4/Preoperative Checkout Procedure WARNINGS Do not perform the preoperative checkout procedure while a patient occupies the incubator. Complete the Preoperative Checkout Procedures section of this manual before putting the unit into operation. If the incubator fails any portion of the checkout procedure it must be removed from use and repaired. In this section Mechanical checks Mechanical checks Accessory checks Controller checks Operational checks WARNING Disconnect the power cord for the mechanical portion of the preoperative checkout procedure. 1. Disconnect the power cord for the Care Plus Incubator for the mechanical portion of the preoperative checkout procedure. 2. Examine the power cord for damage. Replace the power cord if damage is evident. 3. Examine the incubator for obvious signs of damage. 4. Lock the two front casters and check that the unit is held in place. Release the locks and verify the unit moves smoothly. 5. On the cabinet, open the cabinet front doors (if present) and verify that the four incubator mounting knobs that attach the Care Plus to the cabinet are secured tightly in place. 6. Rotate both front door latches toward the center of the incubator, verify the red stamp is visible on both latches, and lower the door. Make sure that the inner wall is securely fastened to the door. WARNING The front door inner wall must be in place while a patient occupies the incubator

24 4/Preoperative Checkout Procedure 7. Make sure that the front door is securely fastened to the incubator. 8. Check that the mattress and the mattress tray are properly installed. Verify that you must lift the tray slightly to slide it out of the hood. This prevents the tray from sliding out accidentally. Slide the mattress tray back into the hood. 9. Check the portholes. Open the portholes by pressing on the latch. The cover should swing open. If arm cuffs are installed, the elastic cuff band should fit into the groove around the porthole without obstructing the cover. Close the porthole and verify that the mounting posts hold the porthole securely to the hood and that the latch holds the porthole closed. 10. If the optional inner wall is installed, check that it is securely attached to the outer wall. To attach the inner wall, insert the two outside inner wall fasteners in the key holes in the inner wall and slide them along the slots until the wall is in position. Lock the wall in place by snapping the two inside fasteners into the holes in the middle of the inner wall. 11. Check that the tubing access covers are also installed on either side of the hood. 12. Check the hood tilt latch. Open the front door. Rotate the hood back approximately 30 degrees, until it locks into position. Push against the hood and make sure that it is held in place. To close the hood, support the hood and release the hood latch by pushing back on the release tab. Gently lower the hood. 13. Close the front door and rotate the latches upward. Verify that the red stamp on the latch is masked by the opaque patch on the hood. 14. Check the operation of the tilt mechanism. Rotate the tilt handles down to raise the bed until it locks in position, then rotate the handles up to return the bed to its original position. 15. Check that the controller is latched in position. The controller latches should be all the way down, parallel with the sides of the controller. 16. Locate the humidifier fill tray (if present) on the underside of the base. Slide the fill tray out. Verify that the seals are in good condition and that there is no obvious damage to any of the humidifier components. Slide the humidifier back in and push until it locks in position. Push it back until you feel slight resistance, then push harder till it snaps into position. Otherwise, verify that the plugs are in place. 17. Unscrew the two filter mounting knobs on the rear of the incubator, lift off the vented filter cover panel and check the condition of the filter. If the filter is dirty, has been used with an infectious patient, or has been in use for three months, it must be replaced. When you replace the filter, mark the date on the label supplied with the replacement filter. Affix the label to the side of the incubator. Accessory checks 1. Check that all accessories are securely mounted. 2. Check the operation of any accessories with reference to the appropriate operation and maintenance manuals. 3. Set up any required suction or gas supply systems. Check them for leaks as outlined in the appropriate operation and maintenance manuals

25 4/Preoperative Checkout Procedure Controller checks WARNING Do not use the Care Plus in the Presence of flammable anesthetics; an explosion hazard exists under these conditions. Patient Control Mode and Patient Probe (available on Care Plus 2000 only) Note: The Enable switch must be pressed to activate the temperature adjustment, the Override or the control mode switches. These switches remain active as long as the enable indicator is illuminated (approximately 12 seconds after the last time one of these switches is pressed). Note: If the patient probe reading is below 22.0 C (71.6 F), LLLL appears in place of the patient temperature. Note: All silenceable alarms are preceded by a 30 second operator prompt tone. 1. Make sure the power cord is connected to the socket on the right side of the controller. 2. Plug the patient probe into the labeled connection on the left side of the controller. 3. Line up the air temperature sensor connectors. Plug the air temperature sensor into the labeled connection on the left side of the controller. 4. Route the patient probe cord through the tubing access cover and place the patient probe inside the incubator. 5. Plug the power cord into an appropriately rated power source (see rating plate for proper voltage, etc.). 6. Switch the power On and verify the following sequence: a. An alternating two tone audible alarm sounds for approximately five seconds, all the indicators illuminate and appears in the three temperature displays. b. All indicators are extinguished except for the air control and the enable indicators. The temperature displays change to show from left to right: Patient Air Control Temperature Temperature Temperature XX.XX (software 60H (AC frequency; 39.0 C (maximum version, for ex:01.01) 50H for 50 Hz units) air control temperature) c. An operator prompt tone sounds, and the control temperature display flashes 33.0 C. The operator prompt tone will sound every two seconds until a control temperature is entered by pressing one of the temperature switches (? or M). d. If the system failure alarm sounds, note the error code and switch off the unit. Wait ten seconds and switch the unit back on. If the system failure alarm recurs, remove the incubator from use. Then, call for service

26 4/Preoperative Checkout Procedure 7. Adjust the control temperature to silence the prompt tone. 8. Check display illumination and the audible alarm by depressing the Alarm Silence switch until all the indicator LEDs illuminate and appears in the three temperature displays (approximately five seconds). An audible alarm will sound. 9. Check the Enable switch. Press the Enable switch. The enable indicator should illuminate and go out after approximately 12 seconds. Verify that pressing the temperature switches (? and M) has no effect when the enable indicator is extinguished. 10. Check the analog to digital calibration and the line voltage. Depress the Enable switch until the temperature displays show, from left to right (approximately five seconds): Patient Air Control Temperature Temperature Temperature C (±0.2 C) C (±0.2 C) From to (low calibration point) (high calibration point) (Service use only) Note: An audible alarm will sound to indicate that the actual temperatures are not displayed. 11. Check the patient probe. Warm the patient probe by placing it between your fingers. Verify that the displayed patient temperature increases. If you have an ASTM approved thermometer, accurate to ±0.1 C, place the thermometer and the patient probe in a glass of warm water. Stir the water and wait several minutes until the thermometer reading stabilizes. Verify that the patient temperature shown on the control panel is within 1 C of that shown on the thermometer. Replace the probe if the difference exceeds 1 C. 12. Check the normal range of air control temperatures. Press the Enable switch to activate the temperature switches (? and M). The enable indicator will illuminate. Press and hold the? switch. Verify that the lowest control temperature attainable is 20.0 C. If the enable indicator has gone out, press the Enable switch again. Depress the M switch and verify that the air control temperature cannot be set above 37.0 C. 13. Check the extended range of air control temperatures. With the control temperature set to 37.0 C, sequentially press the Enable and Override switches. The enable indicator should illuminate and the override indicator should blink. Depress the M switch and verify that the maximum air control temperature is now 39.0 C. The override indicator will blink as long as the control temperature setting remains at, or above, 37.0 C. 14. Check the F/ C switch. Adjust the control temperature to 36.0 C and press the F/ C switch. Verify that the control temperature is now displayed as 96.8 F. Press the switch a second time to return to a Celsius display

27 4/Preoperative Checkout Procedure 15. Switch to the patient control mode of operation. Press the Enable and the Patient Control switches and verify the following sequence: a. The enable and the patient control indicators illuminate. b. The control temperature display flashes 36.5 C and an operator prompt tone sounds every two seconds. Adjust the control temperature to silence the prompt tone. The enable indicator will be extinguished approximately 12 seconds after the last time one of the temperature switches (? and M) is pressed. Note: A patient temperature alarm will be triggered if the patient probe temperature differs from the control temperature by more than 1.0 C. If the probe temperature is below 30.0 C or above 42.0 C the heater will not switch On. 16. Check the range of patient control temperatures. Press the Enable switch to activate the temperature switches (? and M). The enable indicator will illuminate. Press and hold the? switch. Verify that the lowest control temperature attainable is 35.0 C. If the enable indicator has gone out, press the Enable switch again. Depress the M switch. Verify that the patient control temperature cannot be set above 37.0 C. Note: The maximum patient control temperature can be raised to 37.5 C by internal adjustments specified in the service manual. 17. Check the patient temperature alarm. Press the Enable switch and adjust the patient control temperature until it exceeds the patient temperature by more than 1.0 C. An alarm should sound, the patient temperature should flash and the patient temperature alarm indicator should illuminate. Press the Enable switch and adjust the patient control temperature until it is within 0.8 C of the patient temperature. The alarm should cancel. Note: Service personnel can configure the alarm to trigger if the difference exceeds 0.5 C and to reset when the difference is less than 0.3 C. 18. Check the probe failure alarm. a. Unplug the patient probe from the controller. Verify that an alternating two tone alarm sounds, the probe failure LED illuminates, HHHH flashes in the patient temperature display and the heater power LEDs are extinguished. Plug the probe back in and verify that the alarm cancels. b. Unplug the air temperature sensor from the controller by pushing in the back of connector while pulling back on the T handles. Verify that an alternating two tone alarm sounds, 00.0 C flashes in the air temperature display, the probe failure LED illuminates, and the heater power LEDs are extinguished. Align the connectors and plug the air temperature sensor back into the controller. Verify that the alarm cancels

28 4/Preoperative Checkout Procedure 19. Check the power failure alarm and the battery backed memory. Verify that you are still in the patient control mode. Adjust the patient control temperature to 36.0 C. Switch to the air control mode and adjust the control temperature to 35.0 C. Unplug the incubator. An intermittent, nonsilenceable alarm should sound and the power failure LED should illuminate. All other displays and indicators will be extinguished. Wait two minutes and plug the incubator back in. Verify that the alarm cancels and the unit returns to the air control mode of operation with a control temperature of 35.0 C. Switch to the patient control mode and verify a control temperature of 36.0 C. Note: A fully charged battery should supply the power failure alarm for approximately 10 minutes. If the alarm is tested for the full 10 minutes the incubator must be run for at least two hours to recharge the battery before it is used with a patient. Total recharge time is 8 to 10 hours. 20. Check the Alarm Silence switch. Unplug the air temperature sensor and press the Alarm Silence switch. Verify that the alarm is silenced for one minute. Reconnect the air temperature sensor. Note: The functionality of the remainder of the alarms is continually checked by the microprocessor software during normal operation. If a fault occurs in any of this circuitry, an indicator lights and a tone is sounded. Computer independent circuitry continuously measures and compares the incubator temperature with a factory set level. Visual and audible alarms are activated and the heater is shut-off if the incubator temperature exceeds this pre-set level, independent of the software. Additionally, a computer independent watchdog circuit will reset the computer, turn off the heater, and activate the alarms in the event of a microprocessor failure or software error. Operational checks 1. Make sure that the incubator is in the air control mode. 2. Verify that the front door, the portholes and the hood are closed. 3. Set the control temperature as close to the air temperature as possible. Allow the air temperature reading to stabilize. Verify that the air temperature remains within 0.5 C of the control temperature for five minutes after stabilization

29 5/Using the Incubator WARNINGS Complete the Preoperative Checkout Procedure section of this manual before putting the unit into operation. If the incubator fails any portion of the checkout procedure it must be removed from use and repaired. Do not leave the patient unattended when using the incubator. Check the patient s temperature at least every half hour. For maximum patient monitoring over an extended period of time, select the patient control mode of operation. Residual ether or similar gases exhaled by a post surgical patient may be decomposed by the heater to produce formaldehyde. The optional patient probe is not isolated from earth ground. Any additional equipment used with the Care Plus must comply with UL 544, CSA 22.2, IEC 601, and VDE 750. Do not use the Care Plus or the in the presence of flammable anesthetics; an explosion hazard exists under these conditions. Using an incubator with a fan motor that has worn parts can produce unacceptable noise levels within the incubator. Direct sunlight or other radiant heat sources can cause an increase in incubator temperature to dangerous levels. CAUTIONS Proper temperature control depends on continuous, unobstructed air circulation. Do not cover air circulation openings around the bed as obstruction will result in loss of air circulation, loss of heat, and carbon dioxide buildup. Do not mount or rest a radiant warmer or incandescent light on or over the incubator hood; ineffective heating and damage to the hood may result. If using incandescent phototherapy lamps, check manufacturer s recommended minimum distance to hood. In this section Note: Because the mattress tray is radiopaque, x-ray plates must be placed directly under the infant. Basic operating procedure Responding to alarms Air circulation alarm Control temperature alarm High air temperature alarm Patient temperature alarm Probe failure alarm Power failure alarm System failure alarm Additional operating procedures Accessing the patient Raising and lowering the hood Trendelenburg and reverse Trendelenburg positioning Administering oxygen Using the optional humidifier

30 5/Using the Incubator Basic operating procedure This section tells you how to setup and use the incubator in the air and the patient control modes. For more detailed information on humidifier setup, oxygen administration, opening and closing the door, or Trendelenburg or reverse Trendelenburg positioning, refer to the section Additional operating procedures at the end of this chapter. WARNINGS Always set the brakes before placing a patient in the incubator. On units equipped with a humidifier the humidifier must be installed for proper incubator operation, even if you do not plan to use the humidifier. 1. Verify that the air temperature probe is connected to the controller and that the humidifier or the hole plugs are installed. Plug the incubator into a power outlet and set the caster brakes. If desired, fill the humidifier (if present), position the mattress tilt, and set up any additional equipment. 2. Use the temperature switches (? and M) to enter the control temperature. The normal range for air control temperatures is 20.0 to 37.0 C. 3. To select a control temperature above 37.0 C, adjust the control temperature to 37.0 C, make sure the enable indicator is still illuminated, and press the Override switch. If the enable indicator has gone out, the Enable switch has to be depressed before the Override switch will function. 4. Select either Celsius or Fahrenheit temperature readings with the F/ C switch

31 5/Using the Incubator 5. For optional patient control mode operation, connect the patient probe. For air control mode operation, the patient probe is optional. Connect it only if you wish to display patient skin temperature. a. If you plan to use the patient control mode, use steps 2 and 3, as appropriate, to preheat the incubator to the air temperature required to maintain the desired skin temperature. b. Place the metal side of the skin temperature probe on the patient s skin over the liver area of the infant s abdomen. Attach reusable probes with a heat reflecting patch. Remove the paper protecting the hypoallergenic adhesive of the Heat Reflective Patch and secure the skin temperature probe to the patient s skin with the adhesive side of the patch (Figure 5-1). Do not remove the heat reflecting foil. c. If the patient is prone, place the skin temperature on the patient s back, where it will not be against the mattress. If the probe is between the patient and the mattress, it will produce false readings. WARNING Intimate contact between the skin temperature probe tip and the patient s skin must be maintained to assure accurate skin temperature measurement. Under or over heating may result from poor contact between the skin temperature probe and the patient. Check this attachment regularly to assure the patient s safety. CAUTION Avoid placing excessive strain on the skin temperature probe lead. Always remove the probe from the patient by grasping and removing the heat reflective patch first, then remove the probe from the patient or the patch. Always remove the probe by grasping the plug at the panel. Do not pull on the probe lead. d. Connect the skin temperature probe to the unit. Note: The disposable probe comes with the heat reflecting pad attached. Heat Reflecting Patch with Reflective Side Facing Up White Paper Protector Patient Probe (Place the metal side in contact with the infants skin) CI Figure 5-1 Attaching the patient probe to the infant

32 5/Using the Incubator e. Route the wire through the left tubing access cover and plug the probe connector into the side of the controller. Refer to Figure 5-2. If the ambient temperature is less than 22.0 C (71.6 F), LLLL appears in place of the patient temperature until you attach the probe to the infant. WARNINGS Use only the Reusable Ohmeda skin temperature probe (Stock No ) and Heat Reflective Patches (Stock No , 50/ pkg) or the disposable probe (Stock No ,10/pkg; Stock No , 50/pkg) to monitor the patient s skin temperature. Use of other manufacturer s probes may affect the accuracy of equipment operation and the electrical safety of the patient. In incubators equipped with radiant or phototherapy lamps, the skin temperature probe should be located on the patient s skin in an area which is directly in the path of the radiant heat. It should not be attached to an area which is shielded from the radiant heat or between the patient and the mattress. Large temperature gradients and very long servo response times will result from improper probe placement. Rectal temperatures must never be used to control a patient s temperature. Air Temperature Sensor Patient Probe Patient Probe Connector CI Air Temperature Sensor Connector Figure 5-2 Connecting the patient probe to the Care Plus 2000 incubator

33 5/Using the Incubator Responding to alarms 6. If you plan to use the patient control mode, verify that the incubator has warmed up to the Desired Environmental Temperature. Then press the Enable switch followed by the Patient Control switch: a. The patient control and the enable indicators illuminate. b. The control temperature display flashes 36.5 C and an operator prompt tone sounds every two seconds. The alarm will continue to sound until you enter a control temperature. The heater will not operate unless a control temperature is entered. Note: When patient control mode operation first begins, a patient temperature alarm may trigger. Silence the alarm and attend the patient. This alarm triggers normally if the patient probe temperature differs from the control temperature by more than 1.0 C. If the probe temperature is below 30.0 C or above 42.0 C, the heater will not switch On. WARNINGS Excessive EMI levels in the hospital environment can trigger the system failure alarm. Note the error code and switch off the unit. Wait ten seconds and switch the unit back on. If the system failure alarm recurs, remove the incubator from use. If an alarm is silenced, closely monitor the patient. Note: Refer to the troubleshooting section in Chapter 7 for problems that do not involve an alarm indicator. Many things can trigger alarms. For example: a patient s condition may change; a patient probe may detach; or a change in the control temperature may increase the difference between the control temperature and the monitored temperature (air or patient) to an unacceptable level. If an alarm triggers: Evaluate the patient Attend the infant. Identify the alarm Check the indicators to identify the active alarm. When two or more alarms are active, their respective indicators illuminate. If an indicator illuminates, look the alarm up alphabetically in this section. If two or more alarms have been triggered, the audio signal sounds for the highest priority alarm. Silencing the alarm If desired, silence the alarm. At the end of the silence period the audio alarm reactivates unless the alarm condition has been resolved. The length of the alarm silence period depends on the alarm. Power failure and system failure alarms cannot be silenced. Another alarm prematurely ends the alarm silence period. 30 second operator Prompt tone All silenceable alarms are preceded by a 30 second operator prompt tone, in order to minimize disturbance to the infant

34 5/Using the Incubator Air circulation alarm Air is not circulating through the incubator. The most common cause is a missing fan or a fan that is not rotating. If the alarm continues, stop using the incubator and call for service. Control temperature alarm The air temperature is 1.5 C above or 3.0 C below the air control temperature (air control mode alarm). The control temperature alarm is automatically silenced for 30 minutes after you switch on the unit and for 15 minutes after you change the control temperature or switch to the air control mode. 1. Evaluate the patient: Opening the incubator door causes some heat loss. If the incubator starts out cold, or you make a large change in the control temperature, the incubator may take longer than the automatic alarm silence period to warm up. 2. If the alarm continues, stop using the incubator and call for service. High air temperature alarm The air temperature exceeds fixed limits: Control High Temperature Mode Temperature Alarm Limit Patient Control Entire Range 40.0 C (104.0 F) Air Control 20.0 to 37.0 C 38.0 C (100.4 F) (68.0 to 98.6 F) 1. Evaluate the patient: 37.0 to 39.0 C 40.0 C (104.0 F) (98.6 to F) Have you changed the air control temperature? In the air control mode, decreasing the control temperature below 37.0 C decreases the alarm limit from 40 C to 38 C. Making this change while the incubator temperature exceeds 38 C triggers the alarm. Have you changed operating modes? The same thing can happen if you switch from the patient control mode (alarm limit 40 C) to the normal air control mode (alarm limit 38 C). 2. Press the alarm silence button and monitor the patient. This alarm does not self cancel if the temperature falls below the alarm limit. You must press alarm silence to reset it. 3. If the alarm recurs, stop using the incubator and call for service

35 5/Using the Incubator Patient temperature alarm (Care Plus 2000 only) The patient temperature differs from the patient control temperature by more than 1.0 C or the patient temperature is outside the 30.0 to 42.0 C range (patient control mode alarm). Note: Service personnel can adjust this alarm to trigger at a temperature difference of 0.5 C 1. Evaluate the patient: Opening the incubator door causes some heat loss. Control temperature changes can temporarily increase the difference between the patient and the control temperatures. 2. Make sure that the patient probe is properly connected to the patient: the metal side of the probe must make good contact with the infant s skin. With a reusable probe, you must also attach a separate reflecting patch. Make sure the metal side of the patch faces up. 3. If HHHH or LLLL appears in the patient temperature display while the patient probe is properly connected to the patient, replace the patient probe. 4. If the alarm continues, stop using the incubator and call for service. Probe failure alarm (Care Plus 2000 models only) One of the temperature sensors is disconnected or contains an open or shorted circuit. In the air control mode: 1. If 00.0 appears in the air temperature display, plug the air temperature sensor into the controller. 2. If the alarm continues, stop using the incubator and call for service. In the patient control mode: 1. If 00.0 appears in the air temperature display, plug the air temperature sensor into the controller. 2. Make sure that the patient probe is plugged into the controller. 3. If HHHH or LLLL appears in the patient temperature display and the patient probe is plugged into the controller, replace the patient probe. 4. If the alarm continues, stop using the incubator and call for service

36 5/Using the Incubator Power failure alarm The incubator is switched on, but it is not getting any power. 1. Make sure that one end of the power cord is plugged into the controller and that the other end of the cord is plugged into a power outlet. 2. Plug another device into the outlet to verify that the power outlet has power. 3. Replace the power cord. 4. If the alarm continues, stop using the incubator and call for service. System failure alarm Excessive EMI levels in the hospital environment can trigger the system failure alarm. Note the error code and switch off the unit. Wait ten seconds and switch the unit back on. If the system failure alarm recurs, remove the incubator from use. Then, call for service. Additional operating procedures This section provides more information on opening the hood, using the humidifier, and administering oxygen. Accessing the patient Opening the front door: Opening the front door gives you total access to the patient without affecting the air flow. To lower the door, rotate the door latches down (Figure 5-3). WARNINGS Do not leave the infant unattended while the front door or the portholes are open. When opening or closing the front door or the portholes, make sure that the infant, any clothing, the monitoring leads, etc., are completely within the confines of the bed. Opening the porthole: To open a porthole, press in on the latch until the porthole opens. To close a porthole, push the cover shut until the latch clicks into position

37 5/Using the Incubator Porthole Latch Door Latch CI Figure 5-3 Opening the front door Pulling out the mattress tray: Pulling out the mattress tray facilitates procedures that require total access to the infant. This can only be done when both tilt mechanisms are at their lowestposition. Lower both tilt mechanisms, lift the tray slightly at the edge of the doorand gently pull the tray out (Figure 5-4). WARNINGS While sliding the mattress tray out, make sure the square tabs on the back corners of the tray are engaged in the guide tracks at both ends of the platform cover. When sliding out the mattress tray, carefully guide any tubes or monitoring leads through the tubing access covers. If there is insufficient slack or the tubing gets stuck, the attached devices could accidentally disconnect or the patient could be harmed. CAUTION Do not operate the tilt mechanisms when the mattress tray is pulled out. The tilt mechanism may jam as a result

38 5/Using the Incubator Mattress Tray CI Figure 5-4 Pulling out the mattress tray Raising and lowering the hood WARNING Do not raise the hood when a patient occupies the incubator. Raise the hood only for hood disassembly and cleaning. The hood can be raised to facilitate cleaning. The hood tilt latch on the right rear corner of the incubator holds the hood open. To tilt the hood, push on the tab on the hood latch and rotate the hood back until it locks in position. See Figure 5-5. To return the hood to its normal position, support the hood and release the hood tilt latch by pushing back the release tab on the latch. Then slowly lower the hood. Press Here Front Door (Open Position) Hood Latch Figure 5-5 Raising the hood CI

39 5/Using the Incubator Trendelenburg and reverse Trendelenburg positioning-tilt handle models CAUTION Do not use the tilt handles to maneuver the incubator. Tilt handles on the front of the unit, allow ten degree Trendelenburg (feet up) or reverse Trendelenburg (head up) positioning. Tilting the mattress: 1. Grasp the tilt handle on the side of the mattress that you wish to raise (Figure 5-6). 2. Rotate the tilt handle down until it locks in position to raise the corresponding side of the mattress. WARNING Verify that the mattress is locked in position before releasing the tilt handle. Returning to the horizontal position: To return the mattress to the horizontal position, rotate the handle up to lower the mattress. Portholes Air Temp. Sensor Front Door Latch Tilt Handle CI Figure 5-6 Tilting the mattress

40 5/Using the Incubator Administering oxygen WARNINGS Additional oxygen should only be administered under the direction of qualified medical personnel. The use of head boxes, hoods and oxygen inlets can increase the noise level inside the incubator. Remove all sources of ignition including smoking materials, and sources of electrical discharge from the area when oxygen is in use. In the presence of high oxygen concentrations, even relatively nonflammable items can ignite and burn rapidly. Do not place auxiliary equipment producing sparks inside the incubator. Even small quantities of highly flammable items (such as organic cleaning solvents) may explode. Ensure the controller is seated and latched prior to administering oxygen. You can increase the internal incubator oxygen concentration by connecting an oxygen source to the inlet on the right hand side of the incubator. Either pipeline or regulated cylinder supplies may be used

41 5/Using the Incubator Oxygen Inlet CI Figure 5-7 Connecting oxygen supplies 1. Connect the output of the oxygen flow meter to the inlet fitting on the right hand rear corner of the incubator (Figure 5-7). WARNING Always use a back pressure compensated flow meter to deliver oxygen to the incubator. Other flow meters may not compensate for the back pressure created by the oxygen inlet and could deliver incorrect flow rates. 2. Set up an oxygen analyzer to monitor the hood oxygen concentration. Position the sampling tube or sensor near the center of the infant compartment. Route the tube or sensor cable out the hood through one of the tubing access covers. WARNINGS Monitor the oxygen concentration at a position near the infant s head. The concentration vs flow rate chart on the side of the incubator gives only approximate concentrations to aid in setting the initial flow rate. It must not be used in place of an oxygen analyzer. Use an oxygen monitor whenever oxygen is being administered. Concentration of inspired oxygen does not predictably determine the partial pressure of oxygen in the blood; blood gas measurements are extremely important for the regulation of inspired oxygen concentrations when an oxygen enriched environment is necessary. Oxygen concentrations above 40% can increase the risk of retrolental fibroplasia (retinopathy of prematurity). Even concentrations of 40% or less oxygen (formerly considered safe) could be dangerous to some infants. (See current edition of Standards and Recommendations on Hospital Care of Newborn Infants prepared by the Committee on Fetuses and Newborns of the American Academy of Pediatrics.)

42 5/Using the Incubator 3. Switch On the incubator. Unless the incubator is operational, there will be no air flow to ensure adequate mixing inside the hood. 4. Set up the initial flow rate using the oxygen concentration table next to the oxygen inlet. The chart will give you a general idea what flow rate will be required to maintain the desired concentration. The actual concentration will vary with the condition of the incubator air inlet filter, hood seals, door seals and the number of open portholes, as well as the infant s condition. 5. Wait 30 minutes and then check the oxygen concentration inside the unit, without opening the hood. Adjust the flow rate if required. Allow 30 minutes between adjustments for the new concentration to stabilize. Using the optional humidifier WARNING The humidifier must be installed for proper incubator operation, even if you do not plan to use the humidifier. The Care Plus offers three levels of humidification: none, low, and high. If you do not want humidification, do not put water in the humidifier. Even at the high setting, the humidifier reservoir holds more than enough water to last for 24 hours. 1. Gently slide the humidifier out of the base. You will feel an initial resistance, but apply a steady pull to avoid spilling its contents (Figure 5-8). 2. Set the humidifier down on a level surface and add water to the fill level indicated on the label (1000 ml maximum). Note: Do not fill the humidifier past the fill level. Filling past the fill level actually DECREASES humidification. 3. Slide the humidifier back into the base. 4. Adjust the slide on the side of the humidifier to set the humidification level: For high humidification move the slide completely back. For low humidification move the slide completely forward. Drain the humidifier when the unit is not in use. Disinfect the humidifier weekly or after each patient. Refer to the section Cleaning and disinfecting individual components in chapter 6 for disinfection instructions

43 5/Using the Incubator Lid Slide Humidifier CI Figure 5-8 Using the humidifier

44 Notes

45 6/Maintaining the Incubator WARNINGS The heater is hot enough to cause skin burns. Unplug the incubator and allow the heater to cool before disassembly or cleaning. Always disconnect the power before performing service or maintenance procedures detailed in this manual. Apply power only if you are specifically instructed to do so as part of the procedure. Thoroughly air dry the incubator after cleaning it with flammable agents. Small amounts of flammable agents, such as ether, alcohol or similar cleaning solvents left in the incubator can cause a fire. Never oil or grease oxygen equipment unless a lubricant that is made and approved for this type of service is used. Oils and grease oxidize readily, and in the presence of oxygen, will burn violently. In this section Cleaning schedule Cleaning schedule Disassembling the incubator for a complete cleaning Cleaning and disinfecting individual components Humidifier Patient Probe (Reusable) Controller assembly Porthole Compartment Temperature Probe Other Clear Plastic Parts Lower unit (mattress, mattress tray, base platform cover, etc.) Oxygen inlet Cabinet This schedule lists the minimum frequencies. Always follow hospital and local regulations for required frequencies. Weekly or after each patient Disinfect the humidifier if it was used. Perform a complete cleaning and if necessary disinfect the entire incubator. Check the air filter; replace the air filter after use with an infectious patient. Check the front door and the porthole latches and hinges to make sure that they will not open accidently. Quarterly Replace the air filter. When the incubator is not in use, use standard analytical methods to make sure that the infant compartment and any direct contact components, such as the humidifier and the oxygen inlet, meet hospital cleanliness standards

46 6/Maintaining the Incubator Disassembling the incubator for a complete cleaning If the incubator has been exposed to body fluids, check your hospital s infection control procedures. You may need to wear protective clothing and eye wear or use special sterilization agents and cleaning procedures. WARNING Disconnect the power cord before disassembling or reassembling the lower unit. CAUTIONS Electronic devices in the microprocessor controller are susceptible to damage from discharges of static electricity. These devices are adequately protected, but can be damaged if the unit is disassembled beyond that recommended for cleaning and maintenance. Do not remove the air temperature sensor mounted to the rear hood wall; the air temperature sensor must remain in the correct position for proper incubator operation. 1. Turn the power switch Off and unplug the unit from the power outlet. 2. If the incubator was previously on, allow it to cool for at least 30 minutes. 3. Remove the filter by unscrewing the two filter mounting knobs on either side of the vented rear panel. Pull off the panel and remove the filter. WARNING The air filter cannot be cleaned and must be replaced every three months, when visibly dirty or after use with an infectious patient. If the air filter is exposed to liquids or disinfectants, replace it with a new filter. 4. Unplug the power cord from the right side of the controller. 5. Unplug the air temperature sensor and the patient probe (if present) from the controller. 6. Pull up on both controller latches and slide the controller forward, out of the lower unit. Be careful not to bump the heater or the fan. They may grate against each other or the base platform if they are knocked out of alignment. 7. Open the incubator door and tilt the hood back to its locked position. Remove the inner wall by pressing up on the center of the wall until it flexes enough to free the two inside inner wall fasteners from their holes, then slide the wall toward the incubator so that the two outside inner wall fasteners slide along their keyhole slots and out the large holes at the slot s end. See Figure 6-1. If the optional rear inner wall is installed, it may be removed in a way similar to the front inner wall

47 100% 75% 50% 25% F / C >37 C 6/Maintaining the Incubator CI Figure 6-1 Removing the inner wall 8. Lift out the mattress and the mattress tray (Figure 6-3). 9. Remove the tilt assemblies. See figure 6-2 1) Lift the tilt handle out of its slot. 2) Pull the tilt rod just a little up out its hole 3) Turn the handle down 90 4) Tilt the assembly all the way back while turning it in another 90 5) Grasp the rod where it enters the hole and pull it straight out. 10. Lift out the base platform cover. 11. Remove the optional humidifier. Slide the humidifier out from under the base. Remove the seals on the portholes. 12. Remove the iris cuff by streching its elastic band off the frame and tightening ring. Snap the tightening ring off the frame. Remove the gasket from the frame. Push the frame out of the hood. Reverse the steps for assembly. Replace the porthole seals. To install new arm cuffs, slip the larger elastic ring over the housing of the porthole. To reattach the inner wall, insert two outside inner wall fasteners in their keyhole slots and slide the wall until the two inside inner fasteners pop into their holes

48 100% 75% 50% 25% F / C >37 C 100% 75% 50% 25% F / C >37 C 100% 75% 50% 25% F / C >37 C 100% 75% 50% 25% F / C >37 C 100% 75% 50% 25% F / C >37 C 6/Maintaining the Incubator cm CI , 034, 035, 036, 037 Figure 6-2 Removing the tilt handle

49 100% 75% 50% 25% >37 C 6/Maintaining the Incubator Mattress Tilt Assemblies Mattress Tray Base Platform Cover Filter Cover Filter Base Platform Lid Slide Humidifier (optional) F / C Controller CI Figure 6-3 Disassembling the lower unit

50 6/Maintaining the Incubator Cleaning and disinfecting individual components CAUTIONS Clean the incubator at least once a week or after each patient. Do not clean the incubator with organic solvents, scouring compounds, strong acids, or strong bases. These compounds may damage the incubator. Divide the components according to cleaning methods. Methods other then those detailed in this section may damage the incubator. Humidifier CAUTION Do not use peroxide or alcohol solutions to clean the humidifier tray. Disassemble the humidifier. Clean the interior with a mild detergent-disinfectant solution. Rinse and thoroughly dry the parts before reassembly. The humidifier may be pressure steam sterilized up to a maximum of 15 minutes at 240 F (116 C) and 15 psig (103 kpa). To avoide part distortion: Do not exceed 15 minute maximum Do not place parts on top of one another Place all items on a flat surface Rinse and dry all parts before sterilizing

51 6/Maintaining the Incubator Patient Probe CAUTIONS Avoid placing excessive strain on the probe lead. When cleaning, be careful not to pull on or bend the lead at the probe tip. Always remove the probe from the incubator by grasping the plug at the panel. Do not pull on the probe lead. Do not apply cold sterilization or cleaning solutions to the probe connector. Note: The reusable, Ohio patient temperature probe, Stock No , is an expendable part as specified in the warranty. 1. Determine if the patient probe is disposable or reusable: Reusable probes have black connectors and use a separate, heat reflecting patch. Disposable probes have a white connectors and come with a smaller heat reflecting patch already attached. Note: Disposable skin temperature probes cannot be cleaned. 2. Clean the skin temperature probe by gently wiping with a soft damp cloth containing a disinfecting agent safe for use on the probe materials. The following lists some cleaning solutions that may be used safely: Generic Formulation Sodium Hypochlorite Glutaraldehyde 2% Hydrogen Peroxide 6% Iodophor Solution 0.27% Maximum Concentration Level 0.5% Aqueous Solution CAUTIONS Use of cleaning/disinfecting solutions containing chemicals not listed above (i.e. alcohol, acetone, etc.), or chemicals in greater concentrations than those listed above, may damage the probe. Do not autoclave or gas sterilize the skin temperature probe. Do not immerse the probe in liquid cleaner. Avoid placing excessive strain on the probe lead. Always remove the probe by grasping the plug at the panel. Do not pull on the probe lead. These precautions will avoid damage to the probe

52 6/Maintaining the Incubator Controller assembly CAUTION If you fill the cleaning tank past the fill mark, cleaning solution can leak into the controller electronics. Controller parts that do not contact the infant Wipe the front panel, the top cover, the side panels, and the rear panel with a damp cloth and a mild detergent solution. Do not apply cleaning solutions onto or near the probe connectors. Heater and fan assembly Remove any lint build up from the rear of the controller. Wipe the fan, the motor shaft and the controller surfaces to which these items are mounted, with a cloth dampened in the cleaning solution. Use a minimum amount of solution. Do not spray on the cleaning solution or permit it to contact any electrical parts. Alternatively, lower the back of the controller into the cleaning tank accessory. Refer to Figure 6-5. CAUTIONS Never substitute any other container for the controller cleaning tank (Stock No ). Do not clean the fan sensor with hydrogen peroxide. Bulkhead Controller CI Cleaning Tank Figure 6-3 Cleaning the controller CAUTIONS Do not autoclave or gas sterilize any of the plastic parts. Do not use strong acids or strong bases on plastic parts

53 6/Maintaining the Incubator Porthole The following cleaning agents are acceptable for cleaning and disinfecting the porthole: Isopropyl Alcohol, 70% concentration Hydrogen Peroxide, 6% concentration (such as Endo-Spor 100% strength) Cavicide Spray, 100% concentration as sprayed from the can (active ingredients - Diisobutylphenoxyethyl dimethyl benzyl ammonium chloride.25%, Isopropanol 14.85%). Idophor Solution, 0.27% concentration (active ingredients - Polythoxy polypropoxy polyethoxy ethanoliodine complex 9.10%, nonyl phenoxypoly [ethyleneoxy] ethanoliodine 8.74%, provides 1.6% minimum Titratable iodine, such as Wescodyne- mixed 2 fl. oz. to 1 gal. H 2 O) Note: this solution will stain porthole seals and bumpers yellow. The following cleaning agents will damage the material being cleaned and are not recommended: Sodium Hypochlorite, 0.5% (bleach) Quaternary Ammonium, 0.2% concentration (such as Virex) Glutaraldehyde, 2% concentration (such as Cidex Plus) Compartment Temperature Probe Wipe the temperature probe with a cloth dampended with a mild detergent-disinfectant solution, such as Cavicide. Be sure to allow the probe to thoroughly dry before putting the incubator back into operation. Other Clear Plastic Parts CAUTIONS To minimize the generation of static electricity, do not polish the incubator hood with a dry cloth. Do not autoclave or gas sterilize the mattress or any of the plastic parts. Do not use strong acids or strong bases on plastic parts. Clean the hood, the inner wall, and other clear plastic parts of the incubator with a disinfectant-detergent. Make sure that the inner walls have been removed so that all incubator surfaces are exposed. Apply the cleaning solution with a clean cloth or sponge. Dry the plastic parts with a clean damp soft cloth to avoid scratches. Note: Do not allow excess cleaning solution to seep in between plastic parts (for example: between the hood and porthole, or between the hood and the inner wall retainers) where it can not be easily wiped dry with a cloth. Lower unit (mattress, mattress tray, base platform cover, etc.) Clean the base platform cover, the mattress and the mattress tray with a mild detergent-disinfectant solution. The tilt mechanism parts in the patient compartment can be cleaned by immersing them in soap and water or a mild detergent disinfectant solution. Clean the exterior tilt controls by wiping down the exposed surfaces with a cloth dampened with a mild detergent-disinfectant solution. Do not immerse exterior tilt mechanism. Rinse and thoroughly dry the parts before reassembly. Oxygen inlet Clean the oxygen inlet with a mild cleaning solution or disinfectant. Cabinet Clean the cabinet with a mild cleaning solution. Apply the cleaning solution with a clean cloth or sponge. Dry the cabinet with a clean, soft cloth

54 6/Maintaining Notes the Incubator

55 7/Service Procedures In this section Repair Policy Repair Policy Maintenance schedule Operator maintenance Service maintenance Troubleshooting incubator problems Warranty repair and service must be performed by an Ohmeda Service Representative or at the Ohmeda Service and Distribution Center. To contact an Ohmeda Service Representative, call the nearest Ohmeda Regional Service Office listed on the back cover. Do not use malfunctioning equipment. Make all necessary repairs or have the equipment repaired by an Ohmeda Service Representative. Parts listed in the service manual, for this product, may be repaired or replaced by a competent, trained person who has experience in repairing devices of this nature. After repair, test the equipment to ascertain that it complies with the published specifications. CAUTIONS Only competent individuals trained in the repair of this equipment should attempt to service it as detailed in the Service Manual (Stock Number ). Detailed information for more extensive repairs is included in the service manual solely for the convenience of users having proper knowledge, tools and test equipment, and for service representatives trained by Ohmeda. Maintenance schedule The unit should be maintained in accordance with the procedures detailed in the Service Manual. Quarterly and two year maintenance must be performed by a technically competent individual as described in the Repair Policy. Operator maintenance This schedule lists the minimum frequencies. Always follow hospital and local regulations for required frequencies. Weekly or After Each Patient Disinfect the humidifier if used. Clean the incubator and check the air filter. Disinfect the incubator if required or after use with infectious patients. Quarterly Replace the air filter. When you replace the filter, mark the date on the label supplied with the replacement filter and affix it to the filter cover panel. Note: This is the minimum replacement frequency. The filter must also be replaced whenever it appears dirty, or has been used with an infectious patient

56 7/Service Procedures Service maintenance This schedule lists the minimum frequencies. Always follow hospital and local regulations for required frequencies. Quarterly Perform the electrical safety and checkout procedure from the Service Manual. If possible verify an acceptable sound level within the infant compartment. Every other quarterly inspection, check the calibration as detailed in the Service Manual. Every Two Years Replace the battery. Inspect all seals and gaskets. Replace shock mounts and bushings. Note: The battery is used to sound the power failure alarm and to power memory circuits during a power failure. Troubleshooting incubator problems WARNINGS Excessive EMI levels in the hospital environment can trigger the system failure alarm. Note the error code and switch off the unit. Wait ten seconds and switch the unit back on. If the system failure alarm recurs, remove the incubator from use. If an alarm is silenced, closely monitor the patient. Symptom Possible cause(s) Recommended action(s) Controller does not Power is off or the power Connect the power cord. energize cord is disconnected Switch the power on. Unit will not heat in Probe temperature Warm probe above 30 C Patient Control Mode* below 30 C All LEDs go out while Open circuit breaker For controllers with serial the unit is in use numbers beginning with HBJ and HCE, discontinue use and call for service. For all other controllers, switch the power Off and On to reset the unit. After the second occurrence, discontinue use and call for service. Mode control, Switches are not enabled Press the Enable switch to temperature switches (enable indicator is out) activate the switches. (? and M), or Override switches do not respond Controller failure Discontinue use and call for service. * On units with patient control mode

57 7/Service Procedures Symptom Possible cause(s) Recommended action(s) HHHH or LLLL appears Patient probe jack Plug the patient probe in the patient temperature not properly seated completely into the display in the air control controller. mode Patient probe failure Replace the probe and check the patient. Alarm cannot be silenced Microprocessor failure Discontinue use and call and all indicators are for service. extinguished System failure alarm Electrical failure Note the error code and switch off the unit. Wait ten seconds and switch the unit back on. If the system failure alarm recurs, discontinue use and call for service. Probe failure alarm* Air probe disconnected in Reconnect the air either mode. Air temp. temperature sensor display reads 00.0 in patient control mode. Patient probe disconnected in patient control mode. Patient temp. display reads HHHH Patient probe malfunction Patient temp. display reads HHHH Control unit failure Reconnect the patient probe. Replace the patient probe. Discontinue use and call for service. Air circulation alarm Blower motor failure Discontinue use and call for service. Missing fan Reinstall fan 7-3 Power failure alarm The power cord is not Plug the power cord in. plugged into a live power outlet The power cord is not plugged into the controller One or more indicators fail Electrical failure Discontinue use and call for service. Improper or no Disconnected RS-232 Reconnect RS-232 cable. Serial String cable Unable to achieve On units with humidifier Check humidifier humidification level tray not properly installed Unable to achieve On units without humidifier Check to see if plugs O 2 level plug in base missing are installed 7-3

58 7/Service Notes Procedures

59 100% 75% 50% 25% >37 C 8/Illustrated Parts Base platform and cover assembly Item Stock Number F / C CI Mattress with cover Filter w/replacement date sticker Humidifier, passive (complete, includes 4-7)* Humidifier fill tray Humidifier slide Humidifier lid Humidifier seal 2/pkg * For Servo-Controlled Humidifier see manual

60 8/Illustrated Notes Parts

61 Appendix In this section Care Plus specifications Care Plus specifications...a-1 Electrical specifications...a-1 Performance specifications...a-2 Safety specifications...a-4 Environmental specifications...a-4 Electromagnetic Compatibility (EMC) Specifications...A-4 Mechanical specifications...a-5 Additional Safety Information...A-6 Glossary...A-7 Electrical specifications Power requirements Designed to IEC and IEC specifications 120 Vac 50/60 Hz Models (115 Vac ± 10%, 5.7 Amps) 220 Vac 60 Hz Models (220 Vac ± 10%, 3.0 Amps) Vac 50 Hz Models (220 Vac - 10%, 230 Vac + 10%, 3.0 Amps) 240 Vac 50/60 Hz Models (240 Vac ± 10%, 2.7 Amps) Nominal power consumption 450 watts at maximum heater output Line voltage compensation Heat output compensated for line voltage fluctuations up to 10% of nominal line voltage. Rated Current: 7 Amps Trip Point: 9.8 Amps Minimum Type: Manual Resetting Model: ETA P10 7 Amps A-1 A-1

62 Appendix Performance specifications Patient temperature measurement Range Displayed: +22 to 42 C (71.6 to F) Accuracy*: ± 0.3 C (± 0.5 F) within a range of C Resolution: ± 0.1 C or F Probe Model Numbers: LA003, LA005 (disposable) Probe Interchangeability: ± 0.1 C (± 0.2 F) Air temperature measurement Range Displayed: 5 to 50 C (41.0 to F) Resolution: ± 0.1 C or F Accuracy*: Varies over temperature range Temperature Range Accuracy 5 to 22 C ( F) ± 0.5 C (0.9 F) 22.0 to 42.0 C ( F) ± 0.3 C (0.5 F) 42.0 to 50.0 C ( F) ± 0.5 C (0.9 F) Control temperature ranges Patient Control Mode: 35.0 to 37.0 C (95.0 to 98.6 F), up to 37.5 C (99.5 F) with internal adjustment Air Control Mode: 20.0 to 37.0 C (68.0 to 98.6 F), up to 39.0 C (102.2 F) with control panel Override switch. Thermal performance Temperature Rise Time*: Less than or equal to 20 min Temperature Variability*: 0.2 C (0.4 F) Temperature Overshoot*: Less than or equal to 0.8 C (1.4 F) Note: * These terms are defined in the Glossary. Alarms Indicator and Nonsilenceable Audio Alarm Power Failure Indicator and Silenceable Single Tone Alarm Difference between patient temperature and patient control temperature exceeds 1.0 C patient control mode (can be adjusted to 0.5 C). Air temperature is 1.5 C above or 3.0 C below air control temperature (air control mode; Disabled for 15 minutes after control temperature change and for 30 minutes on power up). Indicator, Silenceable Two Tone Alarm and Heater Shutdown Air temperature sensor disconnected (both modes) Patient probe disconnected or malfunctioning (patient control mode) Air circulation system failure Patient temperature > 42.0 C or < 30.0 C Air temperature > 38.0 C (air control mode w/o Override) A-2 A-2

63 Appendix Air temperature > 40.0 C (patient control mode or air control mode with Override) Indicator, Nonsilenceable Two Tone Alarm, Heater Shutdown and Possible Error Code System failure Operator prompt tone Intermittent audio tone sounds when the unit is first switched On and when the patient control mode is first selected. Tone is silenced when control temperature is entered. The heater will not operate until a control temperature has been entered. On controllers with serial numbers beginning with HBJ, this 30 second tone also precedes all silenceable alarms. Proportional heat control Features zero voltage switching to minimize radiated and conducted EMI. Heater power compensated for line voltage fluctuations of up to 10% of the nominal voltage. Air velocity over mattress Less than 35 cm/sec. Noise level within unit Less than 60 Decibels, A weighted %RH (Incubator) High Setting Low Setting CI Empty Reservoir Incubator Temperature ( Note: RH values shown above may vary by ±10% Humidifier specifications Specification test conditions used to collect data: Room temperature: 25 C Room humidity: 50% RH Readings taken two hours after reaching temperature equilibrium without an infant in the incubator. A-3 A-3

64 Appendix Oxygen concentration within unit 25 to 45% with 5 l/min. oxygen input 35 to 65% with 10 l/min. oxygen input 45 to 75% with 15 l/min. oxygen input Carbon dioxide concentration within unit Less than 0.5% when a 4% carbon dioxide, 96% air mixture is fed into the infant compartment at rate of 0.75 l/min (simulated infant occupancy). Safety specifications Isolation voltage 2500 Vrms 60 Hz from the patient probe to the ac phase and neutral lines for one minute. m IEC Class I Equipment IEC Type B Isolation Mode of Operation: Designed for continuous operation. Protection against ingress of water: Not protected. WARNING The patient probe is not isolated from earth ground. Any additional equipment used with the Care Plus must comply with IEC Leakage current Power supply: 120V 50/60 Hz Leakage current: less than 300 µa Power supply: 220/240 V 50/60 Hz Leakage current: less than 500 µa Self test The microprocessor performs self test and software verification functions when the power is first switched On. Environmental specifications Operating Temperature Range: 20 to 30 C (68 to 86 F) Storage Temperature Range: -25 to 60 C (-13 to 140 F) Operating and Storage Pressure Range: 500 to 1060 hpa Operating and Storage Relative Humidity Range: 0 to 95% Electromagnetic Compatibility (EMC) Specifications All models meet the requirements as specified in IEC Collateral Standard Electromagnetic Compatibility - Requirements and Tests. A-4 A-4

65 Appendix Mechanical specifications Incubator with cabinet Height: Depth: Width: Weight: Casters: Height to bed: cm (53.5 in) 64.8 cm (25.5 in) 88.9 cm (35.0 in) kg (185 lbs) 3 inch diameter, 2 locking, 2 non-locking 92 cm (36 in.) Incubator only Height: 62.2 cm (24.5 in) Depth: 61.5 cm (24.2 in) Width: 83.1 cm (32.7 in) Mattress: 34.8 x 65.0 cm (13.7 x 25.6 in) Maximum Load: 30 lbs. (13.6 kg) Tilt Positions: Two Position: 0 degrees or 10 degrees A-5 A-5

66 Appendix Additional Safety Information Statements This device should only be operated by personnel trained in its operation and familiar with the risks and benefits of this type of device. WARNING To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. WARNING The computer or RS-232 monitor s user program must continuously check the data link. The program should constantly verify connection to the warmer controller and check for updated data. No additional tasks are required to power down the device after clinical use, other than turning off the unit. Isolation of the unit from the supply mains can be achieved by turning off the device with the power switch. WARNING Electrical shock hazard: Before servicing, always unplug the unit from wall power. Symbols The following symbols appear on the unit: Symbol Description Consult accompanying documents. Specifications The product is designed to meet a life span of 7 years. However, with proper maintenance and repairs, the service life can be extended as long as service parts are available. The maximum patient weight is 40 kg (88 lbs). Directives Ohmeda Medical, a division of Datex-Ohmeda, Inc., has declared that this product conforms with the European Council Directive 93/42/EEC Medical Device Directive when it is used in accordance with the instructions provided in the Operation and Maintenance Manual. This symbol indicates that the waste of electrical and electronic equipment must not be disposed as an unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment. A-6 A-6