REF 6100 Patient Warming System Operation/Maintenance Manual Edition 1

REF 6100 Patient Warming System Operation/Maintenance Manual Edition 1 Notice: Cincinnati Sub-Zero Products, Inc. 12011 Mosteller Road Cincinnati, OH 45241 www.cszmedical.com Telephone: 513-772-8810 Fax: 513-772-9119 E-mail: cszinc@cszinc.com Do not operate the SurfaceTemp Warming System before reading this manual or receiving an operator's in-service or educational session. Please review and read warnings, operational information, and instructions for use in this manual. If you have questions or concerns please call customer service, toll free: 800.989.7373. email: medtechsupport@cszinc.com web: www.cszmedical.com SurfaceTemp is a trademark of Cincinnati Sub-Zero Products, Inc., Cincinnati OH USA Copyright 1982, Cincinnati Sub-Zero Products, Inc. All rights reserved. Cincinnati Sub-Zero Products, Inc 12011 Mosteller Rd Cincinnati, OH 45241, USA PMD019-02 RevB

Table of Contents Section 1 Product Description Page 3 Power Unit Patient Warming Pad Section 2 Safety Pages 4-8 Assembly for patient use Positioning the Patient Warming Pad Patient positioning Hazards Environment for use Indications of use Contraindications Power ON/STANDBY Service required Damaged or punctured Patient Warming Pad Oxygen/anesthesia equipment Wall/hospital power supply or outlets Use with portable x-ray equipment Cable inspection Cleaning recommendations OverTemp indicator activated Prescription labeling statement Caution statement Awareness Medication warning Factory service Section 3 Receiving/Installation/Product Setup Page 9-10 Product receiving inspection Installation and product setup Testing audible alarm Testing thermal couple cut off Standby mode Section 12 Technical Help United States and Canada Telephone 1-513-772-8810 Cincinnati Sub-Zero Products, Inc. Toll Free 1-800-989-7373 12011 Mosteller Road Fax 1-513-772-9119 Cincinnati, OH 45241 www.cszmedical.com BEFORE YOU CALL FOR SERVICE... To help us better serve you, please have the serial number of your SurfaceTemp system unit ready when you call for parts or service. The serial number is located on a specification label attached to the unit s rear panel. How to read serial numbers: Example: 131-ST-60000 13 indicates a manufacturing date of the year 2013 1 indicates the quarter (first) -ST- means SurfaceTemp 60000 indicates that this is the 60,000th unit of a certain model IMPORTANT SAFETY INFORMATION Refer to this manual for instructions and operator information. Read and understand all WARNINGS / CAUTIONS before using, prescribing, or servicing the SurfaceTemp System. Cincinnati Sub-Zero Products, Inc. 12011 Mosteller Road Cincinnati, OH 45241 www.cszmedical.com Telephone: 513-772-8810 Fax: 513-772-9119 E-mail: cszinc@cszinc.com 1 26

Appendix 1 Resource Information Section 11 Appendix Cleaning Solutions/Technique and Recommendation Hospital/facility environmental services protocol www.apic.org CDC: 800-232-4636 OHSA: 202-693-1888 Design and Electrical Safety Inquiries: Cincinnati Sub-Zero 800-989-7373 medtechsupport@cszinc.com Regulatory Compliant: IEC 60601-1 IEC 60601-1-2 IEC 60601-1-6 Usability IEC 60601-2-35 ISO 14971 ISO 9001 ISO 13485 Fire Retardant Rating: California #117, UL94HB Fabrics: Anti-Microbial, Anti-Bacterial Not made with natural rubber latex Parts, Warranty, Service or Other Cincinnati Sub-Zero: 800-989-7373 medtechsupport@cszinc.com Table of Contents continued Section 4 Operation of the Power Unit Pages 11-13 Appearance for normal operation Photo: Power Unit Photo: Operator Control Membrane Compatibility with forced air warming devices Duration of use with procedures OverTemp event - Indications of OverTemp event - Operator actions - Audible alarm - Causes of OverTemp Section 5 Cleaning Page 14 Section 6 Troubleshooting Pages 15-16 Section 7 Labeling, Marking, and Symbols Pages 17-19 Section 8 Product Specifications Pages 20-21 Section 9 Electromagnetic Compatibility (EMC) Pages 22-23 Section 10 Manufacturer's Warranty Page 24 Section 11 Appendix Page 25 Appendix 1 - Resource information Section 12 Technical Help Page 26 Cincinnati Sub-Zero Products, Inc., reserves the right to make equipment changes and improvements which may not be reflected in this manual. 25 2

Section 1 Product Description Section 10 Manufacturer s Warranty The SurfaceTemp System consists of: the Power Unit and the operating table Patient Warming Pad. Joining these two elements is a connecting Cable secured to the Patient Warming Pad. The Power Unit is lightweight. It mounts to an IV pole in proximity to the operating table and the anesthesia provider. The Power Unit connects to standard wall power (100-240V) via a hospital-grade power cable which is connected to the back of the Power Unit and controlled by a primary ON/OFF toggle switch. The Power Unit control membrane should be positioned facing the operator. The Patient Warming Pad should be positioned on the operating room (OR) table platform. Any other pads that are not a component of the Patient Warming System should be removed. The Patient Warming Pad is designed to fit on the flat plane surface of the operating room table. The pad is a pressure redistributing design that delivers conductive warming through the upper surface of the pad. The heating surface commences inches from the upper (head area) edge and terminates within inches of the perineal cut-out section. Non-warming head and foot pads are included with the purchase of a standard OR torso pad and may be used at the discretion of the attending clinician. The Cable exits the pad and connects to the Power Unit. This Cable terminates in a connector with multiple pins that are keyed to aid in correct alignment of the connector. The Cable is positioned in the upper right corner of the pad. Approximate warming time from room temperature 21C to 36C is 8 minutes. Limited Life Product Warranty: Cincinnati Sub-Zero warrants the SurfaceTemp Power Unit to be free of defects in material and workmanship for two (2) years and the Patient Warming Pad OrcaSeal for 18 months from the date of initial purchase by the original purchaser of record. Purchaser is identified only as the original facility/location of record to which the product was shipped. Cincinnati Sub-Zero s liability under this warranty and purchaser's exclusive remedy is limited to cost of the materials to repair the defective goods or to replacement of the defective goods, and in no event shall repair or replacement exceed the purchase price. Repair or replacement of defective SurfaceTemp products, Power Unit and/or Patient Warming Pad under this warranty will be made upon prepaid return of the defective product to Cincinnati Sub-Zero. Purchaser is required to contact customer service and to be prepared to discuss and review any malfunction and failure to perform. A Return Material Authorization (RMA) number will be issued for repair or replacement. Customer will be required to send the defective item(s) and issue a purchase order for the return freight cost. In the event the failure-to-perform/defective Power Unit or Patient Warming Pad is the result of misuse, abuse, or failure to follow instructions in this manual or printed upon the warming pad, failure to follow cleaning and dilution instructions as outlined by hospital policy or the cleaning solution manufacturer, then purchaser will be billed for repairs, parts, and associated cost, not to exceed the cost of a new unit. If the unit cannot be repaired by Cincinnati Sub-Zero, but is still covered under warranty, the purchaser will be refunded the prorated value of the unit. An effort should be made by the purchaser to have normal minimal damage repaired or rectified on site, such as repair or replacement of warming pad covers, replacement of damaged cables, and replacement of fuses. In the event of a warranty question or concern call: Cincinnati Sub-Zero, 800-989-7373 E-mail: medtechsupport@cszinc.com In the event a Power Unit or a warming pad requires factory investigation or repair, returning product must be cleaned to an acceptance of usage level by the operating room cleaning standards. Failure to do so will add a cost for cleaning before product investigation can occur. This warranty is in lieu of all other warranties, express or implied, including warranties of the distributor, guarantees implied by sales representatives and others, liability as herein established and limited. 3 24

Section 9 Electromagnetic Compatibility (continued) Section 2 Safety Emissions Test Compliance Electromagnetic Environment - Guidance RF Emission, CISPR 11: 2009, Group 1 The SurfaceTemp System uses RF energy only for Amended A1: 2010 internal function. Therefore, RF emissions are very low and not likely to cause any interference in nearby electronic equipment. Conducted RF Emission, Complies The SurfaceTemp System is suitable for use in all IEC61000:4-2-2008 establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Quasi-Stationary Current Complies The SurfaceTemp System is suitable for use in all Harmonic Emissions, establishments other than domestic and those directly IEC 61000-3-2: 2008 connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Voltage fluctuations/flicker Complies The SurfaceTemp System is suitable for use in all emissions, IEC 61000-3-3 establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Surge IEC61000-4-5:2005 Complies Main power quality should be that of a typical commercial or hospital environment. Voltage Dips & Interruptions Complies Main power quality should be that of a typical commercial or IEC 61000-4-11:2004 hospital environment. If the user of the SurfaceTemp System requires continued operation during power main interruptions, then an uninterruptible power supply or battery supply is recommended. Immunity Complies The SurfaceTemp System is suitable for use in all IEC61000-4-2:2008 establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Magnetic Field Immunity Complies Power frequency magnetic fields should be at levels IEC61000-4-2:2008 characteristic of a typical location in a typical hospital or commercial environment. Radiation Immunity Complies The SurfaceTemp System is suitable for use in all IEC61000-4-2:2008 establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. EFT IEC61000-4-2:2008 Complies Mains power quality should be that of a typical commercial or hospital environment. ESB IEC61000-4-2:2008 Complies Floors should be of the type used in commercial buildings: wood, concrete, or ceramic tile. Synthetic floor covering materials should have at least 30% humidity. Assembly for patient use: The Power Unit should be mounted to an IV pole, preferably on the lower third of the pole. Tighten the IV pole clamp firmly to ensure the Power Unit doesn't move or slide. The hospital-grade wall power cord should be connected to the Power Unit and wall power outlet. The SurfaceTemp System will not function if the Power Unit is not plugged into wall power. Check the connection on the Power Unit and ensure that the toggle switch on the connector is in the ON position. Positioning the Patient Warming Pad: Place the pad on the operating table. Reversing the pad s position on the OR table top edge to bottom edge, or bottom edge to top edge-- does not influence or alter the patient warming function. The top surface is the warming surface and must be positioned facing up. Velcro is secured to the bottom for fastening the pad to the table. The Velcro side should always be turned to face the table's platform and not toward the patient. The pad bottom has securely attached Velcro, instructional labeling, and identity and handling information. The Cable exit site is secured to the bottom corner of the pad. The Cable must be connected to the left side of the Power Unit. The connection site is labeled. Failure to align the Cable or trying to force the connection with the incorrect alignment is not covered by warranty. Damage to the connector is an operator error. Position cable beneath head pad over the end of the OR table closest to the Anesthesthesia position. Positioning cable between Head and Torso section of the table increases potential for cable damage due to adjusting head support. The Power Unit must be correctly connected to the Cable in order for the Patient Warming Pad to work. When Power Unit is correctly connected to power, the unit will default to STANDBY. STANDBY status does NOT provide any warming. To turn the Patient Warming Pad on from STANDBY (to activate warming), the operator must touch "ON" or the TEMP arrow. ON/TEMP arrow selection defaults to 37 C and requires operator input for higher selections. When the Power Unit transfers from "STANDBY" to "ON, the lowest temperature setting of 37 C is the automatic default. The SurfaceTemp Power Unit can only operate with the SurfaceTemp Pad. No other pads or Power Units are compatible! 23 4

Section 2 Safety continued Section 9 Electromagnetic Compatibility Patient positioning: Patients should be positioned as determined by attending clinicians. For maximum warming effectiveness, turn Power Unit to ON prior to patient positioning. Thermal warming will occur within minutes of the patient s positioning upon the Patient Warming Pad. Exact warming time will vary with patient weight, position, and/or other factors. Patient should be positioned toward the center of the pad, not on pad edges. Overlay products such as foam, patient sliders, or gel devices will influence the thermal transfer to the patient. Minimizing overlays is the most desired practice to achieve successful patient warming. Gel pads are heat sinks, and absorb heat from the warming pad and patient. Due to density, successful thermal transfer requires significant time. Gel pads with skin antiseptics (such as Betadine or PVP) saturated into the gel materials or covering can and have been known to cause skin rash, chemical burn, and other adverse events. All applications of skin prep solutions should be dry and applied according to manufacturer's suggestions for application and use prior to commencing the surgical procedure. Hazards: The Power Unit should not be positioned or placed on the OR floor. The Patient Warming Pad should have the Velcro on the bottom aligned with the existing Velcro on the OR table surface. If there is no Velcro on the OR table, please contact Cincinnati Sub-Zero or table supplier for Velcro strips. Gel pads are heat sinks, and absorb heat from the warming pad and patient. Due to density, successful thermal transfer requires significant time. Gel pads with skin antiseptics (such as Betadine or PVP) saturated into the gel materials or covering can and have been known to cause skin rash, chemical burn, and other adverse events. All applications of skin prep solutions should be dry and applied according to manufacturer's suggestions for application and use prior to commencing the surgical procedure. The SurfaceTemp System requires special precautions regarding EMC and must be installed and put into service according to the EMC information provided in this User Manual. Warning: Use of accessories and cables other than those specified may result in increased emissions or decreased immunity of the SurfaceTemp System. The SurfaceTemp System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, carefully observe to verify that it operates normally in this configuration. Guidance and Manufacturer's Declaration - Electromagnetic Emissions The SurfaceTemp System is intended for use in the electromagnetic environment specified below. The customer or user of the system should assure that it is used in such an environment. * Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed FR transmitters, an electromagnetic site survey should be considered. If measured field strength in the location of the SurfaceTemp System exceeds the RF compliance level of 60601-1-2, the SurfaceTemp System should be tested to verify normal operation. If abnormal operation is observed, additional measures may be necessary, such as relocation of the SurfaceTemp System. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structure, objects, and people. Inspect the SurfaceTemp Pad prior to each use. Do not use the pad if excessive wear (such as cuts, holes, or tears) is evident. Technical staff should inspect and contact Cincinnati Sub-Zero or your sales representative. Do not use the Patient Warming Pad if the SERVICE REQUIRED LED is activated. Do not use the Patient Warming Pad in the presence of flammable anesthetics or highly enriched oxygen environments such as oxygen tents or hyperbaric chambers. 5 22

Section 8 Product Specifications continued Section 2 Safety continued Design Quality: General: Power Unit: metal encasement, designed for the environment of the operating room. Cable is designed for standard use and shielded. Pad fabrics and coatings, foams, sensors, and heating element are designed for the standard practices of the OR as well as the OR cleaning protocol. Design Life: Power Unit: 36 months Patient Warming Pad: 30 months Regulatory Compliant: IEC 60601-1 IEC 60601-1-2 IEC 60601-1-6 Usability IEC 60601-2-35 ISO 14971 ISO 9001 ISO 13485 Fire Retardant Rating: California #117, UL94HB Classification: FDA Class II, Thermal Regulating Device, 510K # K113705 Electrical Characteristics: EMC compliance meets IEC 60601-1-2 Power Consumption: 75 W Power Cord: 10 feet Device Rating: 100-240 VAC, 50/60 HZ, Rated power 260W Pad Fuses: 2A, (2 x 5 x 20mm Slo Blo) Certifications: IEC 60601-1 60601-1-2 60601-2-35 Type BF Applied Parts User Information: This device complies with the EMC requirements according to IEC60601-1-2. Radio transmitting equipment, cellular phone, etc. shall not be used in close proximity to the device since this could influence the performance of the device. Particular precaution must be considered during use of strong emission sources such as high frequency (HF) surgical equipment and similar, so that, for example, the HF-cables are not routed on or near the device. If in doubt, contact a qualified technician or your local representative. 21 Damaged pad covers should be serviced by technical staff. OrcaSeal Coat may be repairable, but ONLY with the Cincinnati Sub-Zero approved OrcaSeal repair kit. Contact Cincinnati Sub-Zero customer service to obtain the repair kit. Environment for use: The SurfaceTemp Warming System is designed and intended for use only in a surgical environment. Indications of use: The SurfaceTemp System aids in the function of assisting in maintaining patient warming during perioperative experience for pediatric and adult patients and would be indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol. Device Use Condition: SurfaceTemp Warming System is to be used on a surgical table, in a surgical suite, during surgery and prescribed in accoradance with the prescription labeling statement. The patient is to be centered on a flat SurfaceTemp Pad and attended by clinical personnel responsible for monitoring the patient s vital signs while in use. Contraindications: Turn the Power Unit OFF in all procedures where hypothermic treatment or administration is policy or prescribed. Use of warming devices in patient care procedures requiring hypothermic treatment can or may contribute to an adverse event, i.e. skin damage, skin tissue burns or other types of skin tissue damage from heat. Do not heat or apply against the patient s skin if prep solution or alcohol-based prep solution has saturated gel pads, as this can cause an adverse chemical reaction. All prep solutions should be dried per manufacturer's recommendations when used on patients in conjunction with this device. Power ON/STANDBY: For maximum patient safety, when the power cord is initially connected with wall power the Power Unit will default to "STANDBY" and require the operator to select "ON" or activate via an UP/DOWN temperature selection arrow. When the Power Unit is transferred from "STANDBY" to "ON, the temperature will default to 37 C. Operator action is required to select a desired temperature setting above 37 C. Disruption of wall power will cause the Power Unit to default to STANDBY once power is restored. 6

Section 2 Safety continued Section 8 Product Specifications Service required: Activation of the SERVICE REQUIRED LED indicates service is required. The SurfaceTemp System will not activate if the SERVICE REQUIRED LED is illuminated. When the SERVICE REQUIRED light is on, the following procedures should be implemented: 1) Inspect connectors visually inspect for cleanliness and to ensure correct connection 2) Inspect fuse (on back of Power Unit) 3) Inspect for damaged Cable (see customer service contact information) 4) Inspect for damaged Cable connector pin bent or misaligned (see customer service contact information) Damaged or punctured Patient Warming Pad: In the event of puncture, concern should be for contamination of foams or materials within the pad. Electrical current is not in contact with the pad's cover. Electrical input sites are located at the head end (upper edge) and shielded per the electrical safety requirements. Service is required if the heated OR table pad is punctured to protect from the ingression of fluid for reasons of contamination. Pad should be sealed immediately. A repair kit is available for small tears or punctures to OrcaSeal pads. (See customer service contact information for repair kit.) Oxygen/anesthesia equipment: In any operating room environment, there always exists a risk of explosion during the use of flammable anesthetics/nitrous oxide with ambient air. Care should be taken when using any alcohol-based cleaner or alcohol-based skin prep solutions. Follow facility and manufacturer's guidelines in the use of skin prep products. Wall/hospital power supply or outlets: Use only hospital-approved power cords for connection of the Power Unit to wall electrical outlets. Use of the portable x-ray (C-Arm) with the SurfaceTemp System: Power Unit and Patient Warming Pad are designed to be compatible with x-ray equipment. Cable inspection: This cable should be inspected frequently to ensure that it is in good working order. 1. Physical Size of Power Unit: 8.25 H x 4.25 D x 7.5 W Weight: 5.3 lbs. 2. Physical Size of Pads: Standard warming torso pad: 40-42-44 L x 20 W x 2.5 D Head pads (non-warming): 10-11 L x 20 W x 2.5 D Foot pad (non-warming): 19-23-24 L x 20 W x 2.5 D Full length warming pad: 78 L x 20 W x 2.5 D 3. Patient weight capacity: Not to exceed the operating table maximum weight load 4. Environment for use: Surgical operating room table or like kind surgical platform Recommended Operating Environment: 15 C to 30 C 5. Installation: See Installation /Product Setup section Clamping to an IV pole is suggested 6. Service & Maintenance: See Troubleshooting, Operation, and Cleaning sections 7. Shipping: Standard ground or air freight -20 C to 60 C -Ship Pad Flat 8. Storage: -20 C to 60 C Humidity: 5-95% -Do not roll or fold pad 9. Disposal: Power Unit: recycle metal case and components Patient Warming Pad: vinyl, recycle foam 7 20

Section 7 Labeling, Markings and Symbols continued Section 2 Safety continued Cleaning recommendations: The Power Unit and Patient Warming Pad should be cleaned and disinfected in accordance with hospital OR equipment cleaning/ disinfecting protocol. Pad Cable Connection OverTemp indicator activated: This indicates that one or more of the temperature sensors has measured a temperature above MAX threshold or 2 C above the operator's selection. Activation of the OverTemp Indicator advises the operator that all power to the heating element has been removed. Power will not be returned until sensors measure a temperature less than the 2 C variance or operator's selection. Prescription labeling statement: The SurfaceTemp System is labeled as follows: "Caution: Federal Law restricts this device to sale by or on the order of a licensed health care clinician. Caution: A risk of electrical shock burn or electromagnetic interference may occur with use of HF Surgical Instruments or endocardial catheters while the warming system is in use. Awareness: Operator should monitor the temperature of the patient at regular intervals. Medication warning: Warmed transdurmal medications can increase drug delivery. Connected Cable Factory service required: Power Unit does not exhibit the STANDBY light 1. Ensure the toggle switch on the back of the power unit is ON. 2. Check the STANDBY light. 3. Inspect the fuse on the back of the Power Unit. 4. If no response, contact Customer Service. SERVICE REQUIRED LED is activated 1. Inspect Cable connector to ensure it is clean, not obstructed, not bent, and not damaged in any other way. 2. Check for bent or broken pins within the connector. 3. Inspect the Cable for damage such as cuts. 4. If the SERVICE REQUIRED light remains on, contact Customer Service. Email: medtechsupport@cszinc.com 19 8

Section 3 Receiving/Installation/Product Setup RECEIVING INSPECTION After unpacking the SurfaceTemp System, be sure to inspect the system for concealed damage. Retain all packing material and carefully describe or photograph any damage. Notify the carrier at once and ask for an inspection (in writing). Failure to do this within 15 days may result in loss of claim. Do not return the equipment to Cincinnati Sub-Zero. Call our Medical Technical Service department for further instructions. Section 7 Labeling, Markings and Symbols continued Labeling on Power Unit Back Please view the setup information provided in this manual and/or receive an operators In-service. INSTALLATION AND PRODUCT SETUP STEPS 1. Remove existing operating table pads from the operating table. 2. Position the Patient Warming Pad on the operating table surface and align Velcro attachment with existing Velcro on the table. If the table does not have sufficient Velcro adhesive strips, contact Cincinnati Sub-Zero at 800-989-7373, medtechsupport@cszinc.com. 3. Mount the Power Unit to the designated IV pole. Ensure the IV pole clamp is securely tightened so the Power Unit does not slide down the pole. The recommended position is on the lower third of the pole. 4. Using the power input connection on the back of the Power Unit, connect the unit to the wall power outlet using the provided power cable or a hospital approved cable. 5. Check that the connector toggle switch on the back of the Power Unit is in the OFF position. 6. Connect the Cable from the Patient Warming Pad to the designated connector site on the Power Unit. Visually align; do not force connection. 7. Turn ON Power toggle switch located on back of Power Unit. 'STANDBY LED" will illuminate. Always turn power OFF when connecting or disconnecting 8. Operator can activate warming by pushing the ON/STANDBY button or using the up/down TEMPERATURE SELECT buttons. Patient warming is now active and functioning. Temperature selection options: 37 C, 38 C, 39 C, 40 C, 41 C, MAX Temp. TEMPERATURE SELECT lights will reflect operator's choice. Temperature selection is the desired skin temperature to be maintained. Testing audible alarm: To test the audible alarm, press the ALARM MUTE button and the DOWN arrow key simultaneously. Alarm and light will activate. Releasing the ALARM MUTE button and DOWN arrow key will silence the alarm and the LED will turn off. 9 18

Section 7 Labeling, Markings and Symbols Section 3 Receiving/Installation/Product Setup continued Labeling on bottom of the heated torso pad (Patient Warming Pad) REF Manufactured for: Cincinnati Sub-Zero Products, Inc. 12011Mosteller Road Cincinnati, OH 45241 P: 513-772-8810 www.cszmedical.com cszinc@cszinc.com L OT CENTER PATIENT ON FLAT PAD DO NOT PUNCTURE Testing thermal safety cutoff: A standard heat gun may be used to test thermal safety cutoff. To locate the temp sensors, the operator should run fingers lightly over surface of pad to detect any one of the three small sensors located along the side and center of the pad. Turn heat gun on to blow moderately heated air over the located sensor. The Overtemp light, located on the Power Unit will illuminate, indicating the sensor has detected a temperature over MAX threshold. When Overtemp is illuminated, power to the heating element is, by design, automatically removed and will not resume until temperature returns to safety thresholds. HUMAN USE ONLY NOT MADE WITH NATURAL RUBBER LATEX FLUID RESISTANT STANDBY mode: Selection of STANDBY mode results in the interruption of active warming by the operator. COMPLIANT: IEC 60601-1 IEC 60601-1-2 EMC IEC 60601-2-35 ELECTRICAL: INPUT 48 V dc 2A USE ONLY WITH CSZ CONTROLLER SEE INSTRUCTIONS FOR OPERATION AND CLEANING DO NOT STORE ROLLED OR FOLDED USE ONLY WITH CSZ PATENT PENDING PIN-C SZ001 R evc DEFINTIONS OF SYMBOLS LATEX Product NOT made with Natural Rubber Latex Read instructions before use Shock protection type BF Caution, consult accompanying documents IPX2: Protected against falling water when tilted up to 15 17 10

Section 4 Operation of the Power Unit Appearance for normal operation: Patient Warming Pad is positioned correctly and adhered to the operating table platform surface. Power Unit is tightly fastened to an IV pole near the operating table. Ribbon Cable is connected to the Power Unit via the left-hand port, designated "Warming Pad Connection." Unit is on STANDBY: green light is active. Unit is ON: READY light is active, initial TEMPERATURE SELECT light is illuminated. Power and Pad Unit Section 6 Troubleshooting continued OverTemp EVENT TROUBLESHOOTING Indication of OverTemp event: OverTemp AUTO OFF LED will illuminate red. READY light will be off. Software/hardware actions: The SurfaceTemp software, when connected to wall power, monitors both sensor input and power output to the heating element at all times. Temperature always defaults to the lowest setting when wall power is interrupted or unit is placed on STANDBY. Power input is suspended when any sensor measures a temperature above MAX threshold or 2 C above the operator s selection. Power to the heating element is not available during OverTemp situations; operator cannot override safety program of software. Power will not be returned until sensors measure a temperature less than the 2 C variance or the operator s selection. Operator's actions: None. Operator is required to perform no corrective action. Audible alarm will activate if operator attempts to override "safe/power off action. Audible alarm may be muted by pressing the ALARM MUTE button. Events associated with OverTemp: 1. Operator reduces temperature more than 2 C i.e., 40 C to 37 C. 2. Gel pad high heat event due to thermal aspects of gel pads. 3. Plastic pads or under pads on the OR table retaining heat. 4. Other objects on the Patient Warming Pad blocking thermal transfer to the patient. 11 16

Section 6 Troubleshooting Event CHECK CONNECTOR LED is activated CHECK CONNECTOR LED stays active after reconnection is performed Connector Pins are broken/bent/damaged READY LED does not activate OverTemp light activates; temp selection by operator is MAX OverTemp light activates; temp selection by the operator is below MAX Audible alarm sounds Cable is damaged, wires exhibited Patient Warming Pad is damaged or punctured Head/foot pads are damaged Screws on the Power Unit are missing Fuse failure Patient Warming Pad sensors/ wire is exposed Patient Warming Pad or other pads slide on operating table surface OR table Velcro aged or absent When unit is first turned on, after 2 minutes, red Service Required light illuminates Remedy Connect and disconnect the Cable Ensure pins in Cable connector are correctly aligned Visually inspect connector pins for misalignment and dirt Clean connector and visually reinspect pins Contact customer service, remove pad from use as a warming product Inspect wall power connection for power Inspect Power Unit and wall plug Inspect power toggle switch ON? Inspect fuse on back of Power Unit If all inspections and corrections do not activate LED, contact: medtechsupport@cszinc.com Power has been removed to heating element Temp has been measured over MAX threshold Check for gel or plastic under pads beneath the patient (see below) Operator selected a temperature more than 2 from previous setting For example, moves from 40 C to 37 C temp selection Touch ALARM MUTE button Operator attempted to return power to heating element unit while an overtemp situation occurred Power off; will not return until safe temp reported Contact Cincinnati Sub-Zero, do not use. Vinyl sewn cover should be replaced; cover may be replaced without replacing pad OrcaSeal pad maybe sealable with sealant kit available from Cincinnati Sub-Zero - medtechsupport@cszinc.com Contact Cincinnati Sub-Zero to replace cover or pad Replace pads OrcaSeal pad maybe sealable with sealant kit available from Cincinnati Sub-Zero - medtechsupport@cszinc.com Contact Cincinnati Sub-Zero to replace cover or pad Contact Cincinnati Sub-Zero to replace Replace fuse Rating and Type information located on Power Unit Contact Cincinnati Sub-Zero; do not use, replace pad Align and inspect OR table Velcro Replace Velcro and align with pad Velcro when replacing Velcro available Contact medtechsupport@cszinc.com Locate main power switch on back of unit. Turn power OFF then ON. On face of Control Unit, Touch ON and select desired temperature. Ambient Room Temperature below sensor operational threshold. Temp sensors required additional time to warm to reach operational range. 15 Section 4 Operation of the Power Unit continued Compatibility with forced air warming devices: Studies have shown patients who begin surgery hypothermic can be more successfully warmed using resistive/conductive and convective warming as a dual mode to achieve patient normothermia. Duration of use with procedures: This product is effective for use in procedures of any length. OverTemp event: Illumination of the OverTemp AUTO OFF light indicates that one or more of the temperature sensors has measured a temperature above MAX threshold or 2 C above the operator's selection. Activation of the OverTemp light advises the operator that all power to the heating element has been removed. Power will not be returned until sensors measure a temperature less than the 2 C variance or operator s selection. Indications of OverTemp event: - OverTemp AUTO OFF LED on the operator control board will light red. - READY light will not be illuminated. 12

Section 4 Operation of the Power Unit continued Section 5 Cleaning OverTemp event (continued) Operator actions: The operator is not required to perform any task. Power has been removed from the heating element and cannot be activated until the desired temperature has been measured. Audible alarm: If the operator attempts to turn the unit ON to override the overtemp event and the unit is in an unsafe temperature reporting mode, the audible alarm will sound to advise of an unsafe temperature. Audible alarm is muted by pressing the ALARM MUTE button. Causes of OverTemp: 1. Operator reduces temperature more than 2 C i.e., 40 C to 37 C. 2. Gel pad high heat event due to thermal aspects of gel pads. 3. Plastic pads or under pads on the OR table retaining heat. 4. Other objects on the Patient Warming Pad blocking thermal transfer to the patient. Hospital/facility-approved germicidal cleaning solution should be used for cleaning all surfaces of the SurfaceTemp System, i.e., Patient Warming Pad, Power Unit, Cable, and power cable. The system should be wiped clean after each use following the germicide s directions for use and dilution ratio. SurfaceTemp System should be cleaned per facility standard operating procedures for cleaning/disinfecting OR pads, cables, cords and OR equipment. Staff should refer to facility specific operating room cleaning protocol for between case and terminal cleaning of OR suites and equipment. To clean the bottom of the pad, lift or tilt pad from long side and wipe bottom surface of pad. Heated torso pad should remain flat when cleaning, do not fold or roll to clean or store pad. Cleaning should include a visual inspection of the Power Unit for damage, and checking the connection of the Cable between the Patient Warming Pad and the Power Unit. The Patient Warming Pad and all associated pads should be inspected during cleaning for damage and puncture. Users should not use cleaning or decontamination methods different from those of ordinary practice for cleaning/disinfecting surgical pads or equipment. Users should follow dilution ratios and germicidal cleaning instructions. Varying from manufacturer s suggested dilution and cleaning protocol may cause damage. Check with manufacturer of germicide before varying dilution rate or recommended cleaning protocol. 13 14