Caleo Neonatal Incubator Sw 2.n Instructions for Use 2nd Edition 9 Jan 2015

How to use the Instructions for Use

How to use the Instructions for Use The headline... specifies the subject of the main chapter. for fast orientation and navigation.

Preparation Before using for the first time Mounting accessories

Preparation

The left-hand column... contains text The text provides explanations and instructs the user step-bystep in the practical use of the product, with short, clear instructions in easy-to-follow sequence. z Dots refer to actions. 1 Numbers refer to the illustrations next to the text and to the sequence of actions in the case of operations consisting of several steps.

Before using for the first time Check that all packaging materials have been completely removed (see packing slip in the pack). Check that the mains power supply voltage matches the voltage rating specified on the nameplate (see page 140). z Check that the height above sea level is correctly set (see page 83). z z

Mounting accessories CAUTION When fitting accessories, please note Any mounted accessories should not collide with the unit when adjusting the tilt angle and heigh oft Caleo®. Risk of damage. Install the accessories such that a collision with the device is ruled out. Screw NOTE on pole 38 mm/600 (2M 50 691) or When fitting accessories, please note: Accessories mounted on the handle side do not move with the main unit during the height adjustment of Caleo® (see page 123). Hoses or cables can be stretched during the height adjustment of Caleo. Lay hoses or cables such that they are sufficiently long during the height adjustment. Screw on pole 38 mm/600 (2M50691) or pole 38 mm/310 (2M 50 688) or pole 25 mm/600 (2M 50 689). z Remove the cover plate from the base frame. z Screw the pole fully into the base frame and tighten firmly. Make sure that it is securely held in place.

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The page... contains instructions for use of the unit combine text and illustrations. The information is translated directly into practical actions showing the user how to use the unit.

Observe the maximum loads. Danger of overturning the unit! Pole 38 mm/600 10 kg Pole 38 mm/310 10 kg Pole 25 mm/600 3 kg Distance between the loads and the pole: max. 150 mm Moving the control unit to the opposite side for pole, 38 mm 1 Remove the control unit = loosen the clamping screw. 2 Remove the holder = loosen the clamping screw. On delivery, the control unit is fixed to the 38 mm/310 tube. This tube is secured by a screwed fixing for transport. If required, the tube can be released (recommendation: ask for assistance from specialized technical personnel): 3 Remove both caps from the tube. Insert a screwdriver in the holes and release the tube. To fit the control unit to the adjacent side: Push the holder over the tube and set it to the desired working height. 2 Mount the bracket = tighten the clamping screw. z Set the control unit to the desired working height. 1 Secure the control unit to the holder = tighten the clamping screw.

WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to the medical device or other property. NOTE A NOTE provides additional information intended to avoid inconvenience during operation.

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Safety Information Definition

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The right-hand column... contains illustrations The illustration shows the relationship to the text and the orientation to the device. The elements mentioned in the text are highlighted, and unnecessarydetails are omitted. The user is guided by screens confirming the various steps required for each action.

Table of contents

Table of contents For Your Safety and that of Your Patients

4

Intended Use

6

What's what

8

Preparation

14

Check readiness for operation

32

Operation

40

Cleaning, disinfecting and sterilizing

94

Maintenance intervals

106

Disposal

109

Message – Cause – Remedy

112

Error – Cause – Remedy

118

Technical Data

120

Description

126

Order List

143

Parts List

146

Index

147

3

For Your Safety and that of Your Patients Definition of target groups

Definition of target groups

Maintenance

Users, maintenance personnel and professionals are defined as the target groups for this medicine device. These target groups were trained to handle the medical device and have the necessary specialized knowledge and training, the necessary know how to use, install, prepare, maintain or repair the medical device. Dräger points out that only the defined target groups should use, install, prepare, maintain or repair the medical device. User

WARNING The medical device must be inspected and serviced regularly by professionals who possess the required qualifications due to their training and their experience. Repair of the medical device must also be performed by trained personnel with additional product-specific DrägerService training. Dräger recommends that a service contract is obtained with DrägerService and that all repairs are performed by DrägerService. Dräger further recommends that only authentic Dräger repair parts are used for maintenance. If the above are not complied with, the correct functioning of the medical device may be compromised. See chapter "Maintenance".

Users are persons who may use the medical device in accordance with its intended purpose. Maintenance personnel Maintenance personnel are persons who are responsible to the owner or operator for the maintenance of the medical device. Maintenance personnel are persons who install, prepare or maintain the medical device in working condition. Professionals Professionals are persons who may perform repair jobs or complex maintenance jobs on the medical device.

For Your Safety and that of Your Patients General Safety Information The following WARNING and CAUTION statements apply to general operation of the medical device. WARNING and CAUTION statements specific to subsystems or particular features of the medical device appear in the respective sections of these Instructions for Use or in the Instructions for Use of another product being used with this device. Strictly follow these Instructions for Use

WARNING Any use of the medical device requires full understanding and strict observation of all sections of these Instructions for Use. The medical device may be used only for the purpose specified on page 6 under "Intended use" in connection with a suitable patient monitoring system (see page 5). Strictly observe all WARNING and CAUTION statements throughout these Instructions for Use and all statements on medical device labels. Failure to observe these safety information statements constitutes a use of the medical device that is inconsistent with its intended use.

Safety checks The medical device must be subject to regular safety checks. See chapter "Maintenance". Accessories

WARNING Only the accessories mentioned in the order list have been tested and approved for use with the medical device. Therefore, it is strongly recommended that only these accessories are used in conjunction with the medical device. Otherwise, the correct functioning of the medical device may be compromised. Connected devices

WARNING Risk of electric shock and of device malfunction Any connected devices or device combinations not complying with the requirements mentioned in these Instructions for Use may compromise the correct functioning of the medical device. Before operating any combination of devices, refer to and strictly comply with the Instructions for Use for all connected devices and device combinations. Not for use in areas of explosion hazard

WARNING This medical device is neither approved nor certified for use in areas where combustible or explosive gas mixtures are likely to occur. Safe connection with other electrical equipment

CAUTION Risk of patient injury Electrical connections to equipment not listed in these Instructions for Use or these Assembly Instructions must only be made when approved by each respective manufacturer.

4

For Your Safety and that of Your Patients Definition of target groups

Connection to other devices Device combinations approved by Dräger (see Instructions for Use of the individual devices) meet the requirements of the following standards: – IEC 60601-1 (EN 60601-1st, 2nd Edition) Medical electrical equipment Part 1: General requirements for safety – IEC 60601-1-1 (EN 60601-1-1) Medical electrical equipment Part 1-1: General requirements for safety Collateral standard: Safety requirements for medical electrical systems – IEC 60601-1-2 (EN 60601-1-2) Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility; Requirements and tests – IEC 60601-1-4 (EN 60601-1-4) Medical electrical equipment Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems If Dräger devices are connected to other Dräger devices or third-party devices and the resulting combination is not approved by Dräger, the correct functioning of the devices may be compromised. The owner is responsible for ensuring that the resulting system meets the requirements of the applicable standards. Strictly observe Assembly Instructions and Instructions for Use for each networked device. Patient safety The design of the medical device, the accompanying documentation, and the labeling on the medical device are based on the assumption that the purchase and the use of the medical device are restricted to professionals, and that certain inherent characteristics of the medical device are known to the user. Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device. These Instructions for Use do not contain references to various hazards which are obvious to professionals who operate this medical device as well as references to the consequences of medical device misuse, and to potentially adverse effects in patients with different underlying diseases. Medical device modification or misuse can be dangerous.

CAUTION Risk of patient injury. Do not make therapeutic decisions based solely on individual measured values and monitoring parameters. Patient monitoring The user of the medical device is responsible for choosing suitable monitoring that provides appropriate information about medical device performance and the patient's condition.

Patient safety may be achieved by a wide variety of means ranging from electronic surveillance of medical device performance and patient condition to simple, direct observation of clinical signs. The responsibility for selecting the best level of patient monitoring lies solely with the user of the medical device. Functional safety The essential performance characteristics consist of a controlled and monitored air-conditioning of the incubator interior with user-defined settings for the monitoring functions. – Air temperature – Relative humidity – O2 enrichment (optional) or, if a set limit is exceeded, an appropriate alarm. The medical device is equipped with basic safety features to reduce the possibility of patient injury while the cause of an alarm is remedied. Information on Electromagnetic Compatibility General information on electromagnetic compatibility (EMC) according to international EMC standard IEC 60601-1-2: Medical electrical equipment is subject to special precautionary measures concerning electromagcompatibility (EMC) and must be installed and put into operation in accordance with the EMC information provided on page 139. Portable and mobile RF communications equipment can affect medical electrical equipment.

WARNING Do not connect connectors with an ESD warning symbol and do not touch the pins of such connectors without implementing ESD protective measures. Such protective measures may include antistatic clothing and shoes, touching a ground stud before and during connection of the pins, or using electrically insulating and antistatic gloves. All relevant personnel must be instructed in these ESD protective measures. WARNING Do not use skin temperature control on children who are in a state of shock, or have fever! Skin temperature is considerably higher than usual. The control function would overcool the incubator, resulting in the risk of hypothermia. WARNING Only use the integrated scale to determine the weight of the patient. Failure to follow the Operating Instructions can lead to severe inaccuracies in measuring the patient’s weight. To safeguard critical therapeutic decisions based on the patient’s weight, the weighing result should be checked against a reference measurement on an external scale.

5

Intended Use

Intended Use Therapy system for premature babies and sick neonates up to a body weight of 5 kg or a body length of 55 cm, for the controlled supply of warmth, humidity* and O2 enrichment* in the patient capsule. For the therapy of twins, the total body weight is limited to 5 kg.

Locations of use Clinical environment in which premature babies or neonatesrequire controlled climate parameters. The device may only be used by properly trained personnel under the supervision of qualified medical personnel familiar with the currently known risks and benefits of using an incubator.

Therapy and care options – – – – –

Heat therapy through air temperature control or skin temperature control Humidification O2-Therapy through controlled O2 enrichment Normal and intensive care via access ports or a large front flap Bed with pivoting adjustment for raising and lowering the head

With Monitoring for – – – – –

Air temperature Skin temperature Relative humidity O2 concentration weight*

*

optional equipment feature

6

What's what

What's what What's what... 8 Front view... 8 Side view, connections... 8 Top view, bed... 9 Connections on the back of the Control Unit... 9 Operating concept... 10 Control panel... 10 Screen... 11

7

What's what

What's what Front view 1 Canopy (2M 51 108) 2 Access ports 3 Front flap 4 Handle for transport 5 Housing 6 Drawer (2M 50 565)* 7 Pedals for height adjustment* 8 Height adjustable pillar*/Housing support 9 Connection for water heater (LuerLock) 10 X-ray drawer/removable bed 11 Screen 12 Control panel 13 Pillar element 14 Double wall* (2M 51 150)

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1 2 3 4

10 9

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24

Side view, connections 15 Central alarm indicator 16 Sensor unit, temperature connections 17 Mains power connection 18 On/off switch 19 Fresh air filter flap 20 Connection for O2 control* 21 Water container (2M 50 040)* 22 Tubing grommet (2M 50 385) 23 Side flap 24 Tubing grommet (2M 50 412) 25 Feeding grommet plug (2M 51 109) 26 Trolley castor with direction lock 27 Trolley castors with brakes

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7 7

15

16 23 22 17 18

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*

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optional equipment feature

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27 27

112

20

What's what

Top view, bed 1 2

Spirit levels Hot air duct

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2 223

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Connections* on the back of the Control Unit 3 4 5

Nurse call MEDIBUS* Service RSB (Remote Service Box)

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3 4 5

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optional equipment feature

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Operating concept

Operating concept Control panel these permanently defined keys enable the user to select various functions of Caleo®: 1 Scale* 2 Bed tilt 3 Menu selection/configuration 4 Changeover key: air/skin temperature control 5 Trend display 6 Suppress alarm tone 7 Lock key pad function 8 Rotary knob

12 13 14 15

3 4 5 9 10 6

 Menu

7

Air Skin

8

Visual signals indicate alarm situations 9 Red bar LED** 10 Yellow bar LED*** 11 Power failure alarm Soft Keys These keys, with variable functions defined by different labels on the screen, guide the user through the specific routines of the unit, from preparing for use to shutting down the unit. Depending on the current menu, different soft keys with varying functions and labels are activated. Only the soft keys required for the current menu actually appear. This precaution keeps the display clear, preventing any confusion for the user. When a soft key is pressed, its function is activated and the relevant menu is displayed on the screen. In the standard screen, the soft key labels are as follows: 12 Air/skin temperature 13 Humidity* 14 O2* 15 Day and Night

* Optional equipment feature ** Warning – immediate action is required *** Caution – rapid action is required

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Hard Keys

Operating concept

Rotary knob A single rotary knob is used to select and set parameters. Turn knob = select Press knob = confirm

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Screen By default, the measured values are displayed as numeric values (standard screen). – – – – –

Set values and actual measured values for air temperature/skin temperature Set values and actual measured values for relative humidity* Set values and actual measured values for O2 concentration* Day and Night (to adjust the brightness of the screen) Alarms and warnings

000

The screen display can also include a trend graph.

*

optional equipment feature

11

Preparation

Preparation Preparation... 14 Before using for the first time... 14 Mounting accessories... 14 Doors, ports and bed... 20 Check readiness for operation... 32 Before First-time Use... 32 Before Every Use... 32

13

Preparation Before using for the first time Mounting accessories

Preparation Before using for the first time Check that all packaging materials have been completely removed (see packing slip in the pack). z Check that the mains power supply voltage matches the voltage rating specified on the nameplate (see page 140). z Check that the height above sea level is correctly set (see page 83). z

Mounting accessories CAUTION When fitting accessories, please note Any mounted accessories should not collide with the unit when adjusting the tilt angle and heigh oft Caleo®. Risk of damage. Install the accessories such that a collision with the device is ruled out. NOTE When fitting accessories, please note: Accessories mounted on the handle side do not move with the main unit during the height adjustment of Caleo® (see page 123). Hoses or cables can be stretched during the height adjustment of Caleo. Lay hoses or cables such that they are sufficiently long during the height adjustment.

228

Screw on pole 38 mm/600 (2M50691) or pole 38 mm/310 (2M 50 688) or pole 25 mm/600 (2M 50 689). z Remove the cover plate from the base frame. z Screw the pole fully into the base frame and tighten firmly. Make sure that it is securely held in place. Observe the maximum loads. Danger of overturning the unit! Pole 38 mm/600 10 kg Pole 38 mm/310 10 kg Pole 25 mm/600 3 kg Distance between the loads and the pole: max. 150 mm. Moving the control unit to the opposite side for pole, 38 mm 1 Remove the control unit = loosen the clamping screw. 2 Remove the holder = loosen the clamping screw. On delivery, the control unit is fixed to the 38 mm/310 tube. This tube is secured by a screwed fixing for transport. If required, the tube can be released (recommendation: ask for assistance from specialized technical personnel): 3 Remove both caps from the tube. Insert a screwdriver in the holes and release the tube. To fit the control unit to the adjacent side: Push the holder over the tube and set it to the desired working height. 2 Mount the bracket = tighten the clamping screw. z Set the control unit to the desired working height. 1 Secure the control unit to the holder = tighten the clamping screw.

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z

Preparation Mounting accessories

NOTE Contol unit without space for free swivel movement. Risk of damage to control unit. Make sure there is sufficient space to swivel the unit. WARNING Mounting the control unit on the handle side. Only specialized technical personnel may move the control unit from the wall side to the handle side or vice versa. Else there is danger of wrong installation and therefore, risk of injury to the user. To install the basic pole (2M 50 680), see page 16. Screw in the extension pole 38/600 (2M 50 691) or pole 38/310 (2M 50 688). z Refit the control unit as specified in the Assembly Instructions. z z

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CAUTION The cable to the control unit must not be removed from the cable guides on the basic pole. Risk of damage. Without sufficient swivelling space, the cable may get damaged. Make sure there is sufficient space to swivel and tilt the unit.

Infusion support (2M 21 514) for pole, 38 mm Max. load per hook 3 kg Push the fixing claw onto the stand pillar. Push the infusion holder into the fixing and secure it firmly with the clamping screw.

010

z z

Swivel table (2M 21 186) for pole, 38 mm For small parts, max. load 3 kg z Place the clamp of the swivel table on the stand pillar and tighten the clamping screw.

020

CAUTION Without sufficient swivelling space, the cable may get damaged. Make sure there is sufficient space to swivel and tilt the unit.

15

Preparation Mounting accessories

Compact rail (2M 85 337) for pole, 38 mm Max. load 5 kg.

WARNING Only specialized technical personnel should perform the installation, else there is risk of incorrect installation and therefore, risk of injury to the user. For fixing accessories, e.g. – O2 monitor

1 2

Adjust the height of the compact rail to the required height of the mounted accessory. Fit the compact rail to the pole = push the compact rail over the pole and fasten with the screws.

Bronchial aspiration system (2M 85 125)

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z

Follow the separate Instructions for Use of the bronchial aspirator. Fix the bronchial aspirator holder to the standard rail on the wall side or handle side. z Tighten the clamping lever. z Establish the hose connections.

230

z

Basic pole (2M 50 680) Maximum load 10 kg

WARNING Only specialized technical personnel should perform the installation, else there is risk of incorrect installation and therefore, risk of injury to the user. z

Mount as specified in the Assembly Instructions.

Distance between the loads and the pole: max. 150 mm

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019

For fixing accessories, e.g. – For additional pole extensions, see page 17. – Swivel table (2M 21 186), see page 15. – Monitor support plate (2M 50 085), see page 18.

Preparation Mounting accessories

Shelf 3020 (M 24 678) Maximum load must not exceed 2 kg! Hang the shelf from the standard rail on the wall or handle side and secure in position.

021

z

Pole extensions The following poles can be fixed to the base pole as extensions: – Pole 38 mm/600 (2M 50 691) or – Pole 38 mm/310 (2M 50 688) or – Pole 25 mm/600 (2M 50 689). z

Screw the pole into the base pole as far as it will go and tighten securely. Make sure that it is securely held in place.

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Observe the maximum loads: Pole 38 mm/600 5 kg Pole 38 mm/310 5 kg Pole 25 mm/600 3 kg Distance between the loads and the pole: max. 150 mm

17

Preparation Mounting accessories

Monitor shelf (2M 50 085) The monitor shelf can be mounted on the wall side and/or the handle side. Maximum load must not exceed 20 kg! Shelf for monitor and ventilation equipment.

WARNING Only professionals should perform the installation, else there is risk of incorrect installation and therefore, risk of injury to the user. To mount the monitor support plate, – on the wall side, use a second pole 38 mm (see page 14), – on the handle side, use a second base pole (see page 16) with a pole extension 38 mm (see page 16).

1

Mount as specified in the Installation Instructions. Fit the monitor shelf = slide the shelf over both 38 mm poles and fix in place with the screws.

max. 20 cm

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CAUTION The vertical stability can be affected if the shelf is placed too high. Threat to patient or user. To obtain safe veritical stability, observe maximum installation height.

max. 100 cm

z z

Hose holder for ventilation hoses (84 11 075) Open the front flap. Raise the bed and pull it out of the incubator. Push the mattress slightly to one side. Place the hose holder in the mounting hole in the bed and fasten from underneath with the locking screw. z Replace the bed in the incubator and close the front flap. z z z z

The hose holder can be fixed to any of the four corners of the bed. 2

Clip the ventilation hoses and cables into the clips at the end of the ventilation hose holder.

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18

Preparation Mounting accessories

O2 enrichment with O2 control* 1

Screw the O2 connection hose to the underside of the incubator.

NOTE In case of a loose O2 connection hose a leakage in the compressed gas inlet occurs, supply pressure in the device is too low. Check the hose for tight connection.

1

Insert the probe into the outlet of the central O2 supply pipeline and place it in the "Park" position (see the associated Instructions for Use). The permissible gas pressure is between 300 and 600 kPa.

011

z

O2 monitor Monitoring the O2 concentration with the help of an O2 monitor with alarm limits: z Fix the O2 monitor to the compact rail using the holder. z Place the sensor capsule in Caleo®. z Route the sensor cable through one of the flexible tubing grommets. Where applicable, push the sensor plug into the socket of the O2 monitor (e.g. Oxydig or MiniOx 3000) until it audibly clicks into place (see separate Instructions for Use of O2 monitor).

2

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The contour of the vacuum mattress can be altered as required and is then maintained after air evacuation of the mattress. Extreme positions can therefore be obtained for special applications. The mattress can remain in the incubator. z Open the front flap. z Insert and preform the vacuum mattress. z Place the patient on the mattress and adjust the mattress to the desired shape. z Connect the vacuum mattress to the hose of the suction system. 2 Open the valve and evacuate the vacuum mattress. 2 Close the valve and disconnect the hose. z Close the front flap.

028

Vacuum mattress (2M 17 909)

Fitting the drawer (2M 50 565) Maximum load must not exceed 7 kg.

z

Mount as specified in the Installation Instructions. Fit the drawer = slide the drawer box into the groove in the base frame.

*

optional equipment feature

z

118

WARNING Only specialized technical personnel should perform the installation, else there is risk of incorrect installation and therefore, risk of injury to the user.

19

Preparation Doors, ports and bed

Doors, ports and bed Access ports To open the access port: 1 Press down the knurled area of the locking bolt. The access port opens.

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To close the access port: z Press the access port closed until the locking bolt engages.

Front flap To open the front flap: 2 Turn the two knobs inwards to the vertical position. The red latch becomes visible.

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Lower the front flap until it hangs down vertically towards the floor.

Take care not to trap hoses and cables in the moveable double wall of the front flap!

To close the front flap: Raise the front flap and press into position, 3 Turn the two locking knobs outwards to the horizontal position until you feel them click into place.

WARNING Danger of excessive cooling or overheating of the patient. If the moveable double wall is not parallel to the front flap, the hot air duct is interrupted. The moveable double wall must be positioned parallel to the front flap. Align the moveable double wall if necessary!

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WARNING Flap can open on its own, danger to patients. Make sure that both locking knobs are engaged. The red latches must no longer be visible.

016

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Preparation Doors, ports and bed

Side flap The side flap is opened and closed the same way as the front flap (see page 20).

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z

Double wall* The double wall (2M 51 150) can only be fastened to the canopy (2M 51 108).

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Fitting the double wall 1 Pull the plunger up as far as it will go. The red shaft of the plunger will then be visible. z Place the double wall on the hood.

2 3

Position the centering lugs in the recesses in the hood. Place the bore sleeve of the double wall assembly in the hole for the "feeding grommet" plug. z Lay the contour seal (gasket) of the double wall evenly on the hood.

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2 Securing the double wall 4 Push the plunger down into the sleeve until it engages. The red shaft of the plunger must no longer be visible.

*

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4

optional equipment feature

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