level 1 Convection Warmer Operators Manual ( L1-CW-220V ) Rev 303

Convective Warmer

TO OBTAIN A PAPER COPY: contact Smiths Medical customer service at 1 800 258 5361

G e n e r a l I n f o r m a t i o n

Level 1® Convective Warmer Operator’s Manual Part Number: ML-0001-558 Rev. 303 (04/19) This revision supersedes all previous revisions. Every effort has been made to ensure that the information in this manual is accurate and details provided are correct at the time of printing. The company, however, reserves the right to improve the equipment shown. Mention of third-party products is for informational purposes only and constitutes neither an endorsement nor a recommendation. Smiths Medical ASD, Inc. (“Smiths Medical”) assumes no responsibility with regard to the performance or use of these products. The Smiths Medical and Level 1 design marks are trademarks of Smiths Medical. The symbol ® indicates the trademark is registered in the U.S. Patent and Trademark office and certain other countries. All other names and marks mentioned are the trade names, trademarks, or service marks of the respective owners. For further information, please call your local Smiths Medical distributor or Smiths Medical direct at 1 800 258 5361 or +1 614 210 7300.

©2019 Smiths Medical. All rights reserved.

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Level 1® CONVECTIVE WARMER | Operator’s Manual

C o n t e n t s

Contents 1 About this Manual Indications for Use Conventions Used in this Manual

2 Description Convective Warmer Components

3 Important Safety Information Warnings Precautions

4 User Interface

9 9 9 10 10 12 12 15

Control Panel Controls, Indicators, and Displays

16 16 17

5 Initial Setup and Daily Use

18

Assembly Step 1: Unpack the Convective Warmer Step 2: Attach the Hose to the Convective Warmer Step 3: Install the Convective Warmer Step 4: Perform Electrical, Functional, and Safety Tests

18 19 20 20

Daily Use Step 1: Plug into Mains Power Step 2: Select Convective Warming Blanket Step 3: Attach the Hose to Convective Warming Blanket Step 4: Attach the Sheet Clip to the Sheet Under the Patient Step 5: Using the Convective Warmer Step 6: After Use Step 7: Storage

21 21 22 22 22 23 23

6 Cleaning/Maintenance Cleaning the Convective Warmer and Hose Replace Air Filter

24 24 25

7 Troubleshooting

26

8 Specifications

29

9 Symbols

35

10 Limited Warranty

37

11 Service

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S E C T I O N 1

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A b o u t t h i s M a n u a l

S E C T I O N 1

About this Manual This Operator’s Manual describes the assembly, use, and maintenance of the Level 1® Convective Warmer. This manual is intended for use by individuals trained in the healthcare and biomedical professions. WARNING: These instructions contain important information for safe use of the product. Read the entire contents of this Operator’s Manual, including Warnings and Precautions, before using this product. Failure to properly follow warnings, precautions, and instructions could result in death or serious injury to the patient.

Indications for Use The Level 1® Convective Warmer is intended to prevent and treat hypothermia when temperature therapy is clinically indicated. The warmer can also be used to provide thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Level 1® Convective Warmer can be used with adult or pediatric patients and is intended for use by healthcare professionals in clinical environments.

Conventions Used in this Manual This manual uses the following text and text conventions: Convention

Description

Note

A Note statement alerts the user to important information that requires attention.

WARNING

A Warning statement alerts the user to conditions that may cause death or serious injury to the patient or user.

PRECAUTION

A Precaution statement alerts the user to conditions that may cause malfunction, failure, or damage to the device.

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S E C T I O N 2

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D e s c r i p t i o n

S E C T I O N 2

Description The Level 1® Convective Warming system consists of a high-flow convective warmer with hose-end temperature control, a convective warming blanket, and accessories. The convective warmer draws ambient-temperature air through a HEPA air filter. The filtered air is warmed to a selected temperature. The warmed air enters the convective warming blanket through the hose and is distributed through delivery channels. Perforations on the patient side of the air delivery channels in the blanket gently disperse warm air over the patient. The convective warmer has three outlet temperature settings, which provide flexibility in patient treatment: 37°C, 40°C, and 43°C. These three temperature settings are controlled by thermistors placed at the end of the hose where the hose connects to the convective warming blanket. A fourth temperature setting delivers ambient-temperature air. The temperature at the end of the hose is stable at the set point indicated on the control panel when the selected set point LED stops blinking. The safety circuit provides an independent means of shutoff which discontinues power to the heater. This prevents patient exposure to excessive temperatures. Over-temperature is monitored and alarms separately for each temperature setting. See Appendix A (page 41) for Product and Accessory information.

Convective Warmer Components REAR VIEW (without clamp) and FRONT VIEW 1. Handle – used to lift and move the convective warmer 2. Control Panel – contains controls and displays used during operation

1

2

REAR VIEW 10

FRONT VIEW

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S E C T I O N 2

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D e s c r i p t i o n

Rear View with clamp 3. Pole Clamp (Optional) – mounts the convective warmer on a pole 4. Air Outlet – opening where the hose attaches to the convective warmer 5. Thermistor Receptacle – connection for the thermistor cable 6. Power Cord Receptacle – connector for the power cord (MAINS connect/disconnect)

Rear View with Hose Attached 7. Hose – transports air to the convective warming blanket 8. Hose Nozzle and Elbow – hose end that attaches to the convective warming blanket 9. Air Intake – air enters the convective warmer through the vents located under the top housing

3

4

5

6 7

8 9

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S E C T I O N 3

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I m p o r t a n t S a f e t y I n f o r m a t i o n

S E C T I O N 3

Important Safety Information This section covers information for prescribers and guidelines for safe use of the Level 1® Convective Warmer.

Warnings Death or serious injury may occur to the patient or users if these warnings are not followed: These instructions contain important information for safe use of the product. Read the entire contents of this Operator’s Manual, including Warnings and Cautions (Precautions), before using this product. Failure to properly follow warnings, precautions, and instructions could result in death or serious injury to the patient.

• Thermal injury may occur if convective warming therapy is applied to lower extremities during aortic cross-clamping procedures.

• Thermal injury may occur if convective warming therapy is applied to ischemic limbs. • To prevent thermal injury, closely observe patient's cutaneous circulation distal to arterial cross-

clamping. To prevent thermal injury, do not use the highest temperature setting when treating patients who have poor perfusion.

• Electrocution Hazard. There are no user-serviceable parts inside the enclosure. Only competent

personnel knowledgeable in the safety procedures required for servicing live primary MAINS parts shall be allowed to open the enclosure.

• Grounding reliability can only be achieved when the MAINS power cord is connected to a properly grounded receptacle. Risk of electrical shock exists if the equipment is not connected to a properly grounded receptacle.

• Exposed conductor on the MAINS power cord can cause an electrocution hazard. Remove the device from service if the MAINS power cord has exposed wires.

If mounting to an IV pole using the optional pole mounting clamp, the IV pole must have a minimum of 5 or more legs, a minimum diameter of 1.9 cm ( 0.75 in) and a minimum base diameter of 56 cm (22 in). Failure to use a proper IV pole may cause tipping that may injure the patient or user. While in use, do not mount the convective warmer higher than 116 cm (46 in) from the floor on the IV pole. Mounting the convective warmer above 116 cm (46 in) may result in instability of the pole and cause tipping that may injure the patient or user. The hose must be removed and transported separately or stored within the cart shelf compartment if the convective warmer is being transported while mounted on the cart shelf accessory. Failure to properly transport the warmer could cause tipping that may injure the user or patient.

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S E C T I O N 3

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I m p o r t a n t S a f e t y I n f o r m a t i o n

Warnings [continued] • During use, do not position the convective warmer such that it is difficult to disconnect the power

cord from the wall or from the warmer. Thermal injury may occur if the device cannot be powered off easily if needed.

• In compliance with safety standard IEC 80601-2-35, there is a possible risk of electrical shock, burns,

or electromagnetic interference with the use of High Frequency surgical instruments or endocardial catheters in the presence of active Heating Devices.

• The convective warmer meets the international electrical interference requirements of EN 60601-1-2. MRI, Portable and mobile RF communications equipment, and other such devices can affect the convective warmer.

• Do not operate the convective warmer in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. The risk of explosion exists if the device is operated in a potentially explosive environment.

• To prevent fire hazard and possible damage to the convective warmer, use only fuses specified. Only competent personnel knowledgeable in the safety procedures required for servicing live primary MAINS parts shall be allowed to open the enclosure.

• If so equipped, ensure that the convective warmer IV pole mounting clamp is properly tightened

before each use. Failure to securely mount the convective warmer onto the IV pole may cause it to slide down the IV pole, and injure the patient or user.

• Do not perform maintenance while the convective warmer is operating. Risk of thermal injury exists if the device is operating.

• This device can only be used in conjunction with a Smiths Medical convective warming blanket. For the safe operation of this device, the user must follow all warnings, precautions, and instructions provided in the Instructions for Use supplied with the compatible convective warming blanket, in addition to this Operator’s Manual.

• Continuously monitor patient’s body core temperature, vital signs, and observe cutaneous response at regular intervals to prevent thermal injury. If erythema or instability in vital signs is evident, decrease the temperature setting or discontinue use of convective warming therapy.

• To prevent thermal injury in hypotensive or hypoperfused patients, observe cutaneous response

more frequently. Reduce the temperature setting or discontinue use of convective warming therapy if instability in vital signs or erythema occurs.

• If the patient’s nose or mouth is positioned against the convective warming blanket or the plastic drape, closely monitor the patient’s breathing to prevent suffocation injury.

• Cover all open wounds in contact with the convective warming blanket to prevent airborne contamination.

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S E C T I O N 3

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I m p o r t a n t S a f e t y I n f o r m a t i o n

Warnings [continued] • Use only one convective warmer and one hose. Use of multiple convective warmers in multiple inlet ports of the same convective warming blanket may cause damage to the blanket and thermal injury to the patient.

• To prevent thermal injury, do not allow any of the patient’s body parts to rest on the active hose inlet. Do not allow the hose to contact the patient.

• Use of the device in loud environments may prevent the audio alarm from being heard. Visually monitor patient temperature and device visual indications.

• Do not use a convective warming blanket over transdermal medications (patches) as this may lead to increased drug delivery that may result in patient injury or death.

• To prevent thermal injury to the patient, if Over Temperature alarm sounds and/or Over Temperature

alarm indicator illuminates (Amber), restart, select temperature, and determine if the problem persists before placing back in service. If condition persists, remove from service and contact Smiths Medical or your local Smiths Medical distributor.

• The convective warmer must be serviced by competent personnel authorized by Smiths Medical. Failure to service the device correctly may result in thermal injury to the patient.

• To prevent insufficient or excessive heat therapy, the convective warmer should only be used in operating temperatures of 10°C – 40°C.

• The use of materials of good thermal conductivity, such as water, gel and similar substances, with the convective warmer not operating can decrease the temperature of the body of a patient.

• Use of this equipment adjacent to or stacked with other equipment should be avoided because it

could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

• This device can only be used in conjunction with a Smiths Medical convective warming hose and

power cord. Failure to use this device with the Smiths Medical hose and power cord could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

• Portable and mobile RF communications equipment should be used no closer to any part of the convective warmer, including cables, than the recommended separation distance specified in Section 8, Specifications.

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S E C T I O N 3

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I m p o r t a n t S a f e t y I n f o r m a t i o n

Precautions Malfunction, failure, or damage to the device may occur if these precautions are not followed:

• No modification of this equipment is allowed. • Hose nozzle MUST be connected to a compatible forced air blanket or thermal injury may occur. • If the convective warmer does not perform its self-test properly, fails to operate, or stops while

running, discontinue use of the convective warmer to prevent thermal injury to the patient. Remove the device from service. Contact Smiths Medical or your local Smiths Medical distributor.

• Do not use strong solvents to clean the hose or exterior surfaces. These solutions may damage labels and other parts.

• Never use organic solvents (e.g., acetone), strong acids, or bases to clean any portion of the convective warmer.

• Do not place the convective warmer directly under a faucet or use a faucet sprayer to rinse. Never

spray cleaning or other fluids into openings on the convective warmer or into the external connectors.

• Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

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S E C T I O N 4

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U s e r I n t e r f a c e

S E C T I O N 4

User Interface Operation of the Level 1® Convective Warmer is monitored and controlled by the control panel (User Interface). This section describes the control panel and the modes of operation.

Control Panel The Control Panel provides the controls, indicators, and displays used during operation of the convective warmer. 1. Standby Button 2. Temperature Setting Buttons 3. Operation Indicators 2

1

3

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S E C T I O N 4

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U s e r I n t e r f a c e

Controls, Indicators, and Displays The following table defines each control, indicator, display and the modes of operation.

Control/Indicator

Visual Indicator

Audible Beep

Standby Button/Indicator A solid lit LED indicates that the system is powered on but that the heater is OFF and the blower is OFF.

Green LED

None

Ambient Air Temperature Setting Button When selected, the heater is turned OFF and the blower is ON (air flows).

Green LED

None

37° C Temperature Setting Button When selected, the air temperature is set to 37° C at the hose end. A blinking LED indicates that the system has not yet reached the selected temperature.

Green LED

None

40° C Temperature Setting Button When selected, the air temperature is set to 40° C at the hose end. A blinking LED indicates that the system has not yet reached the selected temperature.

Green LED

None

43° C Temperature Setting Button When selected, the air temperature is set to 43° C at the hose end. A blinking LED indicates that the system has not yet reached the selected temperature.

Green LED

None

Over Temperature indicator Blinking or solid lit Indicator LED indicates that the system has detected a temperature that is too high.

Amber LED

Dependent on condition*

Maintenance indicator Blinking or solid lit Indicator LED indicates that an error has occurred which requires maintenance or that routine maintenance is needed.

Amber LED

Dependent on condition*

Occlusion indicator Amber LED A solid lit Indicator LED indicates that an occlusion in the hose or blanket has been detected.

Dependent on condition*

Definition

*See Section 7, Troubleshooting for error condition remedies and solutions.

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S E C T I O N 5

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I n i t i a l S e t u p a n d D a i l y U s e

S E C T I O N 5

Initial Setup and Daily Use Assembly The Level 1® Convective Warmer must be assembled and tested by authorized Smiths Medical personnel, an authorized distributor of Smiths Medical, or competent personnel prior to placing the convective warmer in service. Read through the instructions completely prior to assembling the convective warmer. The following steps describe how to assemble and do preliminary set up of the convective warmer.

Step 1: Unpack the Convective Warmer 1. Check the contents and verify that all components are present. If any parts are missing or damaged, do not use the convective warmer. Contact Smiths Medical for replacement parts. Refer to the following list of components that are part of the convective warmer:

• Level 1® Convective Warmer • Operator’s Manual CD • Power Cord • Hose • Sheet Clip Assembly • Cord Wrap Note: The Power Cord and Cord Wrap are packaged separately from the Warmer. Note: After unpacking all the contents, please recycle packaging material according to hospital policy for recyclable materials.

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I n i t i a l S e t u p a n d D a i l y U s e

Step 2: Attach the Hose to the Convective Warmer 1. Connect the thermistor cable (a) from the hose to the thermistor receptacle (b) mounted inside the air outlet (c). To connect, align the three prongs in the thermistor with the three holes in the receptacle, then gently push the thermistor inward to secure it in the receptacle. 2. Attach the hose (d) to the air outlet. Push the hose firmly into the outlet.

a

d

c

b

(shown with optional pole clamp installed)

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I n i t i a l S e t u p a n d D a i l y U s e

f

e

(shown with optional pole clamp installed)

Step 3: Install the Convective Warmer The convective warmer can be placed on a flat surface, mounted to an IV Pole, or mounted to the Level 1® Convective Warmer cart. See Cart or Pole Clamp Installation and Use Instructions for installing.

Install Power Cord 1. Insert the plug on the power cord into the power cord receptacle (MAINS connection) (e) on the rear of the Convective Warmer. 2. Push the power cord lock (f) over the plug to secure it in the receptacle. The indicated lock feature is spring-loaded and self-locking. The lock must be intentionally pulled back to release the power cord.

Step 4: Perform Electrical, Functional, and Safety Tests Perform all applicable electrical, functional, and safety tests as required per institutional procedure. Electrical safety check must be performed by competent personnel authorized by the institution to perform such testing. These tests include, but are not limited to: leakage current, ground bond test, and hipot. Refer to the Level 1® Convective Warmer Service Manual for further information about electrical, functional, and safety testing. Perform all safety checks on a routine basis according to institutional policy.

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S E C T I O N 5

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I n i t i a l S e t u p a n d D a i l y U s e

Daily Use The Operating Instructions for the Level 1® Convective Warmer are grouped into six steps. Read through each step before performing a procedure.

Step 1: Plug Into Mains Power 1. Plug the power cord into a properly grounded MAINS receptacle to power on the warmer. 2. Verify that the LED indicators for Standby (a), Ambient Air, 37° C, 40° C, 43° C (b), Over Temperature, Maintenance, and Occlusion (c) all light in turn during the automatic selftest. When the self test is complete the Standby LED lights green. 3. Ensure hose connection to back of warmer is firmly seated. 4. Ensure the standby indicator is lit, signifying electrical power is applied. b

a

c

Step 2: Select the Convective Warming Blanket Warning! Refer to the Warnings and Precautions in the Instructions for Use supplied with each Smiths Medical convective warming blanket. Determine which convective warming blanket is appropriate for the patient. Contact Smiths Medical or your local Smiths Medical distributor for a list of convective warming blankets available.

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I n i t i a l S e t u p a n d D a i l y U s e

Step 3: Attach the Hose to Convective Warming Blanket 1. Insert the hose nozzle (a) into the collar ring (b). 2. Ensure the hose barb (c) snaps into the collar ring (b).

a b b

c

Step 4: Attach the Sheet Clip to the Sheet Under the Patient Attaching the Sheet Clip

d

1. Squeeze the handles (d) on the sheet clip to open the fastener jaws. 2. Insert the sheet into the open jaws (e) and release the handles to lock in place. Note: Proper attachment of the sheet clip to the sheet under the patient is essential to the proper function of the sheet clip assembly.

Step 5: Using the Convective Warmer 1. Press the desired Temperature setting to begin the delivery of therapy. The standby LED indicator will turn off and the selected temperature LED will blink green until the temperature setting is reached. Once the set temperature has been achieved, the temperature LED indicator will be lit green. The temperature setting may be adjusted up or down as required for appropriate therapy by pressing a different temperature setting button. 2. Monitor the patient’s temperature and vital signs continuously. Visually examine the heated skin surface at regular intervals. Adjust the temperature setting or discontinue therapy as required.

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S E C T I O N 5

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I n i t i a l S e t u p a n d D a i l y U s e

Step 6: After Use 1. Press the Standby button to place the system in standby. 2. Remove the hose from the convective warming blanket. Note: Dispose of the convective warming blankets in a safe manner according to local guidelines for disposal of contaminated medical waste. 3. Perform routine cleaning after each use. Refer to Section 6, Cleaning/Maintenance, for more details.

Step 7: Storage Store the convective warmer in a cool, dry place away from temperature extremes. Refer to Section 8, Specifications, for more details.

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