Model 175/215/270 Steam Sterilizer - Skytron

1 Model 175/215/270 Steam Sterilizer powered by Pre- installation Planning guide Skytron 's objective is to provide a program and guideline to assist individuals (hospital owners, architects, structural engineers) responsible for the installation and operation of the Sterilizer . Skytron can provide a set of drawings of the Sterilizer and facility drawings showing the Sterilizer set in its intended position if requested. Signed drawings are required for 270 recessed installations. Skytron is not responsible for local permits and codes. TEC-F-0520 REV1. 04/30. COMPETENCY AND installation REQUIREMENTS. This product is a Class 2 medical device that is subject to FDA Part 820 requirements. installation can only take place by qualified and trained individuals.

2 An installation Qualification Report is required as proof of system operational validation prior to clinical use. Contact Skytron for installation needs. Distributed by: US - Skytron . 5085 Corporate Exchange Blvd. Grand Rapids, MI 49512 (616) 656-2900. The base language for this document is ENGLISH. Any translations must be from the base language document. Printed copies are not controlled documents. Although current at the time of publication, Skytron 'S policy of continuous development makes this manual subject to change without notice. If current manuals are required, contact your local Skytron representative or contact Skytron . directly at the distribution address listed above. Page 1. Skytron RESPONSIBILITIES CUSTOMER RESPONSIBILITIES. 1. Skytron will provide the customer with a data 1.

3 Customer will designate a representative to sheet for 175/215 Sterilizer models or an equipment coordinate and approve the installation . The drawing for (specific) 270 models showing basic customer representative will be responsible for final locations and specifications for all utilities. approval of the work within ten days of completion, 2. Skytron /DISTRIBUTOR will provide the at which time the representative will also approve appropriate specialized technical staff to complete the final Skytron invoice. final system; configuration, power up, and testing. 2. Customer will verify the Sterilizer installation is 3. Skytron will provide specific seismic in accordance with all applicable local codes. calculations, if applicable. Seismic installation 3.

4 Customer will provide Skytron with the should be approved by a structural engineer. appropriate room drawings to include Plan, 4. Skytron will arrange the delivery date and Electrical, and Mechanical Drawings if applicable delivery site details with the transportation company for the project. responsible for delivering the Sterilizer . 4. Customer will supply and install all conduit and Notice electrical junction boxes and complete all electrical connections in accordance with the National For Integrity 270 Model Sterilizer (only) Electrical Code (NEC) and all applicable local and Skytron requires a minimum of 60 state electrical codes. days delivery time from receipt of signed drawings and Order Production-Install Electrical connections must be installed by a (OPI) document.

5 Qualified electrician in accordance with ANSI/. NFPA70 standards, using UL (Underwriters DISTRIBUTOR/REPRESENTATIVE RESPONSIBILITIES Laboratory) recognized materials. 5. Customer will test feed water supply prior to 1. Distributor/Representative will conduct a initial startup. A water test kit and analysis from pre- installation visit(s) to the facility to inspect the Skytron (P/N WQ-TEST) may be purchased, or test site. Identify and document any poor physical locally. If mineral content exceeds the limits below, accessibility for installation and future service. external treatment may be necessary. Measure all openings from the receiving point to the final Sterilizer location. Verify utilities Power/Water/. Drain/ Steam and HVAC for recessed installations.

6 Feed Water Quality Nominal Conditions 2. Distributor/Representative will become aware Total hardness as CaCO : of any safety requirements, union requirements, Sterilizer 50 -120 mg/L, maximum 171 mg/L. applicable local codes and other site specific with conditions that may apply. facility Total Dissolved Solids: 3. Distributor/Representative will notify Skytron , supplied 100 -200 mg/L, maximum 500 mg/L. as soon as possible, of the delivery date and site Steam details, plus any special delivery/freight truck, pH: - , maximum shipping, and/or delivery requirements. Total hardness as CaCO : 4. Distributor/Representative will communicate 0 - 17 mg/L, maximum 130 mg/L. any change orders or project delays to Skytron . 5. Distributor/Representative will make the Total Dissolved Solids: necessary accommodations to unload and move Sterilizer 50 -150 mg/L, maximum 250 mg/L.

7 The Sterilizer into the facility at its final destination. with Integrated Total Silica: This requires appropriate equipment, pallet Steam - mg/L, maximum mg/L. jack, fork lift, or designated lifting device. Generator 6. Distributor/Representative will complete the pH: - , maximum installation Report and Start Up Checklist to comply with FDA's Good Manufacturing Practice and Resistivity: ohm-cm 3,000 - 10,000, max 40,000. Skytron 's Device History Record, sent to Skytron Conductivity: 100 - 300 S/cm, max 25 S/cm immediately after start-up is complete. Sterilizer Pre- installation Planning guide REV1. Page 2. PLUMBING & UTILITY REQUIREMENTS. 6. Customer will provide proper drainage in accordance with applicable local codes. Integrity 175 & 175SG. Temperature of drain water will not exceed 140 Recirculation Tank Overflow Drain.

8 F (60 C) under normal operation. 1 NPT connection provided. 7. Customer will provide all required utilities in place and in working order for Skytron to Sanitary Floor Sink: 12 (305 mm) square x complete Sterilizer installation and testing. 8 (203 mm) deep with minimum 2 ID drain to accommodate peak water consumption of gpm Make sure that house Steam and water lines are (11 Lpm) recommended. properly and completely blown down to remove construction contaminants from the system prior Recirculation Tank Manual Drain ODT. to making the connection to the Sterilizer . A failure to do this could result in unwarranted damage to Cold Water Supply NPT connection provided. the Sterilizer generating additional labor and cost Dynamic Pressure: 30 to 50 psi ( - MPa).

9 To repair. Flow Rate: 6 gpm ( Lpm). Temperature: 50 to 77 F (10 to 25 C). If customer provided systems are not in place and Vacuum breaker, back flow preventer, and shutoff working during the installation , delays may occur valve required. and result in additional charges added to the final invoice. If return trips are necessary due to a lack Jacket Pressure Relief Valve 1" NPT outlet. of customer supplied equipment, additional daily ASME Boiler and Pressure Vessel Code Section charges may occur. VIII, Div. 1, UG-135 piping practices recommended. 8. Customer and/or Distributor will be responsible Check local codes for special requirements. for supply and installation of drywall and trim required for recessed installations. System Electrical Power 13' 4 (4 m) Length Power Cord with 3 prong grounded plug provided.

10 During construction, precautions must be taken to Dedicated Outlet: 120 VAC, 60 Hz, single phase, protect the Sterilizer from the workers/contractors properly grounded and circuit protected outlet and construction materials such as: paint, drywall recommended. compounds, dust, and any other debris. Integrity 175. 9. Customer will become familiar with the warranty coverage requirements, rights, and responsibilities. Facility Steam NPT connection provided. The Skytron Integrity Series Sterilizer includes a Dynamic Pressure: 50 - 80 psi ( - MPa). comprehensive warranty guarantee. Part of the Flow Rate: 65 lb/hour (30 kg/hr). warranty terms requires customer participation Condensate Free 97% - 100% saturated vapor. and action. Integrity 175SG. OPERATING ENVIRONMENT Steam Generator Pressure Relief Valve.