Ohio Care Plus Series 1000 / 2000 Operation and Maintenance Manual Rev A

TableResponsibility User 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

 .S. Federal and Canadian law restrict this device to sale by or on the order of a U licensed medical practitioner.

ii ii

Table of Contents General Precautions Warnings... iii Cautions... iii

1/Introduction Introducing the Ohio Care Plus Incubator... 1-1

2/Getting Started Mounting the Care Plus on the cabinet ... 2-2

3/General Information Operating modes... 3-1 The air control (manual) mode... 3-1 The optional patient control mode... 3-2 Controls and displays... 3-4 Alarms... 3-6 Cable connections and mechanical controls...3-10

4/Preoperative Checkout Procedure Mechanical checks... 4-1 Accessory checks... 4-2 Controller checks... 4-3 Operational checks... 4-6

5/Using the Incubator Basic operating procedure... 5-2 Responding to alarms... 5-5 Air circulation alarm... 5-6 Control temperature alarm... 5-6 High air temperature alarm... 5-6 Patient temperature alarm (Patient control models only)... 5-7 Probe failure alarm (Patient control models only)... 5-7 Power failure alarm... 5-8 System failure alarm... 5-8 Additional operating procedures... 5-8 Accessing the patient... 5-8 Raising and lowering the hood...5-10 Trendelenburg and reverse Trendelenburg positioning-tilt handle models...5-11 Administering oxygen ...5-12 Using the optional humidifier...5-14

ii ii

Table of Contents 6/Maintaining the Incubator Cleaning schedule... 6-1 Disassembling the incubator for a complete cleaning... 6-2 Cleaning and disinfecting individual components... 6-6 Humidifier... 6-6 Patient Probe... 6-7 Controller assembly... 6-8 Porthole... 6-9 Compartment Temperature Probe... 6-9 Other Clear Plastic Parts... 6-9 Lower unit (mattress, mattress tray, base platform cover, etc.)... 6-9 Oxygen inlet... 6-9 Cabinet... 6-9

7/Service Procedures Repair Policy... 7-1 Maintenance schedule... 7-1 Operator maintenance... 7-1 Service maintenance... 7-2 Troubleshooting incubator problems... 7-2

8/Illustrated Parts Base platform and cover assembly... 8-1

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

Table of Precautions General 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 6600-0292-000). 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

Table of Contents Notes

v v

1/Introduction In this section Introducing the Ohio® Care Plus® Incubator... 1-1 How to use this manual... 1-2

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.

CI.23.001

Ohio® Care Plus® Incubator is a registered trademark of Ohmeda.

Figure 1-1 The Ohio Care Plus Incubator 1-1 1-1

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

1-2 1-2

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 ... 2-2

2-1 2-1

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

If mounting hardware is not securely fastened, the incubator could tip off the stand.

CAUTION

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.

CI.23.002

Controller

Controller Lever

Mounting Knob

Figure 2-1 Mounting the Care Plus Incubator 2-2 2-2

3/General Information In this section Operating modes... 3-1 The air control (manual) mode... 3-1 The patient control (servo) mode... 3-2 Controls and displays... 3-4 Alarms... 3-6 Cable connections and mechanical controls...3-10

Operating modes 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.

3-1 3-1

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).

3-2 3-2

3/General Information

Repeat first stage Start

No

Is the PT <30°C?

Stage 1

PT = Patient Temperature PCT = Patient Control Temperat PTG = PT-PCT DPT = Current PT - PT 10 min. previous

Yes 1) Switch heater off 2) Activate alarm Assume probe 3) Keep DET constant is dislodged

Yes Have 10 min passed? Start third stage

No No Is the PT >42°C?

Yes

Yes Infant is cold

Supply maximum heat

No

Is the PTG > 0.5°C?

Infant is hot

Assume probe is dislodged Is the DPT³ 0.2°C?

Is the PTG <-0.5°C?

Yes

Is the PTG³0°C?

Infant is cold

No

Stage 2

Stage 3

Yes Infant is hot

Yes

DET change = 0

Yes

Is the DPT£ -0.2°C?

No PTG -0.5°C -0.4°C -0.3°C -0.2°C -0.1°C -0.0°C

No DET Change 0.3°C 0.3°C 0.2°C 0.1°C 0.0°C 0.0°C

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

Supply no heat

Calculate new DET No

CI.02.068

New DET = Old DET + Change

Figure 3-1 Patient control mode logic diagram 3-3 3-3

3/General Information

CI.23.014

Controls and displays

CI.23.003

Care Plus® 1000

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 107.6°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, 25.05°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, 37.95°C ±0.2°C replaces the air temperature during the test.

3-4 3-4

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 102.2°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 “188.88” 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 / °C

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.

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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

Probe Failure

Control Temp

System Failure

High Air Temp

Power Failure

CI.02.215

Air Circulation

Figure 3-3 Alarm indicators 3-6 3-6

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 37.0° to 39.0°C

38.0°C (100.0°F) 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.

3-7 3-7

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.

3-8 3-8

3/General Information Audio Signal† Mode Possible Causes

Alarm Silence

Heater Status

Alternating All two tone

Disconnected air temperature sensor

1 min.

Off

Patient probe disconnected, open or shorted (patient control mode)

1 min.

Off

Control Intermittent Air Air temperature is 1.5°C Temperature single tone above or 3.0°C below control temperature

15 min.

@

System Alternating All Failure two tone

Electrical malfunction or excessive EMI^ in the 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.

Cannot silence

Off

Air Circulation Failure

See the “Troubleshooting” section in Chapter 7.

5 min.

Off

The difference between the patient temperature and the control temperature exceeds 1.0°C&

15 min.

@

Intermittent Pat. The difference between the single tone patient temperature and the control temperatures exceeds 2.0°C

5 min.

@

Patient temperature is above 42.0°C or below 30.0°C

1 min.

Off

High Air Alternating All Temperature two tone

In the air control mode without override: the air temperature exceeds 38.0°C

5 min.

Off

In the patient control or the air control mode with override: the air temperature exceeds 40.0°C

Power Failure

Power outage while the power switch is on.

Cannot silence

Off

Alarm* Probe Failure

Alternating Pat. two tone

Alternating All two tone

Patient Intermittent Pat. Temperature single tone (Care Plus 2000 only)

Alternating Pat. two tone

Intermittent All single tone

* 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 equipment. @ 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.

3-9 3-9

3/General Information Cable connections and mechanical controls

Portholes Air Temp. Sensor Front Door Latch

Tilt Handle

MAX 1000 mL

CI.23.004

MIN

Figure 3-4 The front of the incubator

3-10 3-10