EQ-5000 Operators Manual Rev 009 Dec 2012

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

EQUATOR® Convective Warmer Operator’s Manual Part Number: 4533900-EN Rev. 009 (2010-12) This revision supercedes 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, and EQUATOR and Snuggle Warm are trademarks of the Smiths Medical family of companies. 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 +1-781-878-8011. ©2010 Smiths Medical family of companies. All rights reserved.

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EQUATOR® 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 Snuggle Warm® Convective Warming Blankets Accessories

3. Important Safety Information 4. Assembly Instructions

Step 1: Unpack the Convective Warmer Step 2: Attach the Hose to the Convective Warmer Step 3: Install the Convective Warmer Assemble the Convective Warmer Cart Mount to an I.V. Pole Install the Power Cord Step 4: Perform Electrical Safety Tests

5. Operation

Control Panel Controls, Indicators, and Displays

6. Operating Instructions

Step 1: Set Up for Use Step 2: Determine the Convective Warming Blanket Size Step 3: Position the Convective Warming Blanket Step 4: Attach the Hose to Convective Warming Blanket Step 5: Attach the Sheet Clip to the Sheet Under the Patient Step 6: Using the Convective Warmer Step 7: After Use Storage

7. Troubleshooting 8. Maintenance

Clean the Convective Warmer and Hose Replace the Air Filter (F3-5000) Functional Tests Test 1: Self-Test Sequence Test 2: Disconnect Indicator Test Test 3: High (44°C) Temperature Test Test 4: Medium (40°C) Temperature Test Test 5: Low (36°C) Temperature Test Test 6: Low Over Temperature and Under Temperature Test Test 7: Medium Over Temperature and Under Temperature Test Test 8: High Over Temperature and Under Temperature Test Test 9: Ambient Over Temperature Test

EQUATOR® Convective Warmer | Operator’s Manual

1 1 1 2 2 3 4 5 9 9 10 10 10 11 11 11 12 12 13 14 14 15 15 16 16 17 19 19 20 22 22 23 24 24 25 25 25 26 26 26 26 27

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C o n t e n t s

9. Accessories

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Cord Wrap (CW-5000) Sheet Clip (SC-5000)

28 28

10. Limited Warranty 11. Service

29 31

Non-Warranty Work Additional Documentation Disposal Information Service Contacts USA/Canada European Representative Australian Representative

31 31 32 32 32 32 32

12. Specifications

33

System Specifications Electromagnetic Environmental Recommendations

13. Symbols A. Convective Warming Blanket Identification Chart B. Position the Convective Warming Blanket C. Ordering Information

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33 34 35 A-1 B-1 C-1

EQUATOR® Convective Warmer | Operator’s Manual

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About this Manual This Operator’s Manual describes the assembly, use, and maintenance of the EQUATOR® 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 Cautions, before using this product. Failure to properly follow warnings, cautions, and instructions could result in death or serious injury to the patient.

Indications for Use The EQUATOR® 5000 Convective Warmer System is intended for thermal regulation of a patient's temperature to prevent hypothermia by a warm air heated blanket system to reduce cold discomfort during and after surgical procedures. It intended for use by appropriately trained 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.

CONTRAINDICATION

A Contraindication statement alerts the user to conditions when the device should not be used.

WARNING

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

CAUTION

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

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Description The EQUATOR® 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 particulate 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: 36°C, 40°C, and 44°C. These three temperature settings are servo-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 indicated on the control panel is the temperature of the air being delivered to the blanket at the end of the hose. A control thermistor adjusts the power applied to the heater to maintain the selected temperature. This enables the system to maintain the selected temperature under variations in ambient temperature. A safety thermistor provides a signal to a separate high-temperature comparison circuit. The safety thermistor activates and causes an alarm if the temperature exceeds the set point. The safety circuit provides an independent means of shutoff, which discontinues power to the heater and motor. This prevents patient exposure to excessive temperatures.

Convective Warmer Components

1

Front View

2

1

Handle - used to lift and move the convective warmer

2

Control Panel - contains controls and displays used during operation

2 EQUATOR E WARMING

CONVECTIV

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Rear View

1

Thermistor Receptacle - connection for the thermistor cable

2

Pole Clamp - mounts the convective warmer on a pole

3

Air Outlet - opening where the hose attaches to the convective warmer

4

Hose Retainer Clip - secures the hose to the air outlet

5

Power Cord Lock - secures the power cord to the receptacle

6

Power Cord Receptacle - connector for the power cord

1

2 3 4 5 6

Rear View with Hose Attached

7

Thermistor Cable - connection from the hose used to transmit a signal from the hose end

8

Hose - transports air to the convective warming blanket

9

Hose Nozzle - hose end that attaches to the convective warming blanket

7

8

9

Snuggle Warm® Convective Warming Blankets The convective warming blanket consists of two layers of non-woven polypropylene fabric coated with a layer of polyethylene. The layers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the blanket through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket. The distribution of air is designed to minimize temperature differences throughout the blanket. Refer to Appendix A, Convective Warming Blanket Identification Chart, for the list of blankets available.

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Accessories The convective warmer is supplied with the following accessories: • Sheet Clip Assembly - secures the hose to bed sheets to keep the convective warming blanket in place • Cord Wrap - keeps the power cord wrapped together

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

CONTRAINDICATIONS • 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.

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, before using this product. Failure to properly follow warnings, cautions and instructions could result in death or serious injury to the patient. • 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. • 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. continued

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WARNINGS (continued) • 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. • Ensure that the convective warmer IV pole mounting clamp is properly tightened before each use. Failure to securely mount the convective warmer onto the I.V. pole may cause it to slide down the I.V. pole, and injure the patient or user. • Do not mount the convective warmer higher than 117cm (46") on the IV pole. For convenience, 117cm (46") is indicated by a black mark on the power cord. Mounting the convective warmer above 117cm (46") may result in instability of the pole and cause tipping that may injure the patient or user. • Do not change the air filter 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 Snuggle Warm® convective warming blanket. For the safe operation of this device, the user must follow all warnings, cautions, and instructions provided in the Instructions for Use supplied with the compatible convective warming blanket, in addition to this Operator's Manual. • Convective warming blankets can only be used in conjunction with the EQUATOR® convective warmer (EQ-5000) and the Snuggle Warm® convective warmer (SW-4000). For the safe operation of the blankets, the user must follow all warnings, cautions, and instructions provided in the Instructions for Use supplied with the compatible convective warmer, in addition to this Operator’s Manual. • Always start therapy on the lowest non-ambient temperature setting to prevent thermal injury. Increase the temperature setting, if required, using core body temperature and cutaneous response of skin in contact with the convective warming blanket as indicators. • To prevent thermal injury, do not use the highest temperature setting when treating patients who have decreased sensation, are nonsensate, or have poor perfusion. • 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. continued

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WARNINGS (continued) • Cover all open wounds in contact with the convective warming blanket to prevent airborne contamination. • The hose nozzle MUST be connected to a Snuggle Warm® convective warming blanket. Do not treat patients with the hose alone. Thermal injury may occur. • 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 place objects onto the convective warming blanket that will obstruct air flow. Items on the blanket can produce localized pressure on the patient’s skin, reducing cutaneous blood flow and causing thermal injury to the patient • For underbody blankets do not place objects, other than the patient’s body, onto the convective warming blanket that will obstruct air flow. Items on the blanket can produce localized pressure on the patient’s skin, reducing cutaneous blood flow and causing thermal injury to the patient. • For the SW-2013 Adult Underbody Convective Warming Blanket, always keep the arms at the patient’s side. Do not allow the patient’s arms to extend outside the blanket as they may obstruct airflow through the blanket. Airflow obstruction may result in insufficient patient warming and loss of therapy. • When replacing the hose, always disconnect the thermistor cable attached to the old hose. Be sure to attach the hose and thermistor cable from the new hose, prior to using the device. Never allow the use of two hoses where one hose is inserted in the air outlet of the device while the thermistor cable from another hose is connected to the device. Failure to replace the hose without replacing the associated thermistor cable may result in an uncontrolled temperature that may cause a serious burn to the patient. • Always place the perforated side of the convective warming blanket, the side with small holes, towards the patient. Failure to do so may result in thermal injury. • Do not use a convective warming blanket over transdermal medications as this may lead to increased drug delivery that may result in patient injury or death. • The convective warming blanket is for single-use only. Reusing the blanket may increase the risk of cross contamination. • Use with the EQUATOR® convective warmer (EQ-5000) and the Snuggle Warm® convective warmer (SW-4000). Using non-compatible convective warmers may cause damage to the convective warming blanket and thermal injury to the patient. continued

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WARNINGS (continued) • Do not sterilize convective warming blankets. Sterilizing blankets may damage the blanket and may cause thermal injury to the patient. • If Over Temperature audible alarm sounds and/or red Over Temperature alarm indicator illuminates, 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. • 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. • The convective warmer must be calibrated by competent personnel authorized by Smiths Medical. Failure to calibrate the device correctly may result in thermal injury to the patient. • Do not use the SW-2008 convective warming blanket if the package is damaged or open. Sterility may be compromised. CAUTIONS Malfunction, failure, or damage to the device may occur if these cautions are not followed: • Do not use alcohol or other 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. • Medical devices require specific material characteristics to perform as intended. These characteristics have been verified for single use only. Any attempt to re-process the device for subsequent re-use may adversely affect the integrity of the device or lead to deterioration in performance. • Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

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Assembly Instructions The EQUATOR 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: • EQUATOR Convective Warmer • Operator's Manual • Power Cord • Hose • Sheet Clip Assembly • Cord Wrap Note: After unpacking all the contents, recycle packaging material according to hospital policy for recyclable materials.

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Step 2: Attach the Hose to the Convective Warmer 1 Attach the hose (a) to the air outlet. Push the hose firmly into the outlet.

2 Move the retainer clip (b) next to the hose. Then lift the clip up over the lip of the hose connector (c) to secure the hose to the air outlet.

b

a

d

3 Connect the thermistor cable from the hose to the thermistor receptacle (d). Align the three prongs in the thermistor with the three holes in the receptacle, then turn the knurled knob clockwise on the thermistor to secure it in the receptacle.

Step 3: Install the Convective Warmer c

The convective warmer can be placed on a flat hard surface, mounted to an I.V. pole, or mounted to the EQUATOR® Convective Warmer cart. Assemble the Convective Warmer Cart 1 Place the pole (a) on the wheels. 2 Insert washers (2) and bolt (b) and tighten. 3 Place the convective warmer (c) on the pole and turn the clamp to tighten.

c

4 Check the tightness of the convective warmer to ensure it is securely clamped to the pole. a b

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WARNINGS • Do not mount the convective warmer higher than 117cm (46") on the IV pole. For convenience, 117cm (46") is indicated by a black mark on the power cord. Mounting the convective warmer above 117cm (46") may result in instability of the pole and cause tipping that may injure the patient or user. • Ensure that the convective warmer I.V. pole mounting clamp is properly tightened before each use. Failure to securely mount the convective warmer onto the I.V. pole may cause it to slide down the I.V. pole, and injure the patient or user.

Mount to an I.V. Pole Note: Do not place the convective warmer higher than 117cm (46") from the floor.

d

1 Place the convective warmer, on the pole and turn the clamp (d) to tighten. 2 Check the tightness of the Convective Warmer to ensure it is securely clamped to the pole. WARNINGS • 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 resulting in death or serious injury to the patient or user. Install the Power Cord 1 Insert the plug on the power cord (e) into the power cord receptacle on the rear of the convective warmer. 2 Push the power cord lock over the plug to secure it in the receptacle.

Step 4: Perform Electrical Safety Tests

e

Perform all applicable electrical 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 hypot. Refer to the EQUATOR Convective Warmer Service Manual (PN 4533902-GB) for further information about electrical safety testing. Perform electrical safety checks on a routine basis according to institutional policy.

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Operation Operation of the EQUATOR® Convective Warmer is monitored and controlled by the control panel. This section describes the control panel and the modes of operation.

Control Panel The Control Panel provides the following controls, indicators, and displays used during operation of the convective warmer.

1

Power ON/OFF Buttons

2

Temperature Setting Buttons

3

Operation Indicators

4

Temperature Display

On some convective warmers the control panel may contain the Elapsed Time Display (5). This function displays in hours (h = hours) the cumulative time use of the convective warmer.

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

Definition Power ON Button The green button powers ON the convective warmer. Power OFF Button The orange button powers OFF operating components of the convective warmer. Note: To remove all power from the convective warmer, the MAINS power cord must be removed from the electrical receptacle. Ambient Air Temperature Setting Button When selected, the heater is turned off and the motor still operates (air flows).

36°C Temperature Setting Button When selected, the air temperature is set to 36°C at the hose end.

40°C Temperature Setting Button When selected, the air temperature is set to 40°C at the hose end.

44°C Temperature Setting Button When selected, the air temperature is set to 44°C at the hose end.

Over Temperature Alarm Indicator If the hose end temperature is more than 3°C (± 1°C) above the selected temperature, the indicator illuminates, a continuous audible alarm sounds, and the heater and motor shut off. Under Temperature Indicator If the hose end temperature is more than 3°C (± 1°C) below the selected temperature, this indicator flashes. Disconnect Indicator If the thermistor cable or the hose is not attached properly, this indicator illuminates, an audible alarm sounds and repeats approximately every five seconds, and the heater and motor shut off. If the heater has an open wire circuit, this indicator illuminates, an audible alarm sounds and repeats approximately every five seconds, the heater shuts off, but the motor continues to operate (air flows). Hose End Temperature Display Displays the temperature of the air at the hose end.

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Operating Instructions The Operating Instructions for the EQUATOR® Convective Warmer are grouped into seven segments. Read through each segment before performing a procedure.

Step 1: Set Up for Use WARNINGS • When replacing the hose, always disconnect the thermistor cable attached to the old hose. Be sure to attach the hose and thermistor cable from the new hose, prior to using the device. Never allow the use of two hoses where one hose is inserted in the air outlet of the device while the thermistor cable from another hose is connected to the device. Failure to replace the hose without replacing the associated thermistor cable may result in an uncontrolled temperature that may cause a serious burn to the patient.

1 Verify that the correct hose, either SW5-HOSE7 (a) or SW5-HOSE-N (b), is attached to the convective warmer. Refer to Section 4, Assembly Instructions, for the procedure to install the hose. Note: When replacing the hose, always remove the thermistor cable with the hose. Never replace the hose without replacing the thermistor cable. Refer to Appendix A, Convective Warming Blanket Identification Chart, for a list of convective warming blankets and the appropriate hose.

2 Verify that the hose thermistor cable is connected to the thermistor receptacle (c) on the convective warmer.

a

c

Note: When using the blue Neonatal hose with the black connector (SW5-HOSE-N), orient the white shield (d) to the left. Do not use the hose retainer clip with this hose. d b

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O p e r a t i n g I n s t r u c t i o n s

Step 2: Determine the Convective Warming Blanket Size WARNINGS • The convective warming blanket is for single-use only. Reusing the blanket may increase the risk of cross contamination. • Cover all open wounds in contact with the convective warming blanket to prevent airborne contamination. • Use with the EQUATOR® convective warmer (EQ-5000) and the Snuggle Warm® convective warmer (SW-4000). Using non-compatible convective warmers may cause damage to the convective warming blanket and thermal injury to the patient.

Determine which convective warming blanket is appropriate for the patient. Refer to Appendix A, Convective Warming Blanket Identification Chart for a description and dimensions of the convective warming blankets that are available. Do not use the convective warming blanket if the package has been opened or is damaged. Do not sterilize blankets. Product meets Consumer Products Safety Commission’s flammable fabric regulation, 16 CFR 1610; however, follow standard safety protocols when using high-intensity heat sources.

Step 3: Position the Convective Warming Blanket Appendix B, Position the Convective Warming Blanket, describes how to position the convective warming blanket. Refer to Appendix B for the procedure to position the specific convective warming blanket being used.

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Step 4: Attach the Hose to Convective Warming Blanket WARNINGS • The hose nozzle MUST be connected to a Snuggle Warm® convective warming blanket. Do not treat patients with the hose alone. Thermal injury may occur.

1 Insert the hose nozzle (a) into the collar ring (b). a

2 Ensure the hose barb (c) snaps into the collar ring (b).

b c

b

3 If the hose has locking tabs (d), secure the hose to the convective warming blanket using the hose retainer wings (e). The hose tabs will protrude through the retainer wings (e).

d

e

e

Step 5: Attach the Sheet Clip to the Sheet Under the Patient Two types of sheet clips are available. Use the method appropriate for your clip. Attaching the New Style Sheet Clip

1 Squeeze the handles (f) on the sheet clip to open the jaws-like opening.

f

2 Insert the sheet into the open jaws (g) 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. The weight of the patient on the sheet helps hold the hose in place when the sheet clip is used. g

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