Service Manual
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SERVICE MANUAL SIGMA INTERNATIONAL MODEL 8000 & 8000 Plus INFUSION PUMPS 44000 REVISION M June 2007
Additional copies of this Service Manual Are available from SIGMA International, Inc. 711 Park Avenue, Medina, NY USA 14103-0756 (Latest revision will be sent unless otherwise specified)
Plus
SIGMA MODEL 8000 & 8000 Plus INFUSION PUMP - SERVICE MANUAL REV. M TABLE OF CONTENTS SECTION 1 GENERAL INFORMATION 1.1
Limited Warranty
1.2
Cautions and Warnings
1.3
Cleaning and Maintenance
1.4
Specifications
1.5
Preventive Maintenance 1.5.1 ITP 35001PM (Preventative Maintenance Procedure) • Visual Inspection • Keyboard Test • Upstream (Proximal) Occlusion Sensor Test • Air Detection Test • Downstream (Distal) Occlusion Sensor Test • Memory Test • Recommended Flow Rate Accuracy Test • Line Safety Analysis • Flow Sensor Operation • Battery Capacity Test
1.6
User Accessible Options
1.7
BioMedical Accessible Options 1.7.1 Instructions for Biomedical Options • Battery Capacity Inspection Sheet ITP 35001BAT
1.8
Troubleshooting Guide
1.9
Service 1.9.1 1.9.2 1.9.3 1.9.4
Return Authorization Field Service Battery Removal and Replacement PROM Upgrade Procedure
SECTION 2 TECHNICAL DRAWINGS 2.0 External Features Figure 2.0.1, Front View, Case Figure 2.0.2, Rear View, Case 2.1 Functional Blocks Figure 2.1.1, Block Diagram 2.2 Cables and Wiring Figure 2.2.1, Cable Diagram 2.3 AC Line Circuit Figure 2.3.0, Schematic, Transformer PCB Figure 2.3.1, Assembly, Transformer PCB
SIGMA MODEL 8000 & 8000 Plus INFUSION PUMP - SERVICE MANUAL REV. M TABLE OF CONTENTS Table 2.3.2, Bill of Material, Transformer PCB 2.4 Regulator PCB Figure 2.4.0, Schematic, Regulator PCB Figure 2.4.1, Assembly, Regulator PCB Table 2.4.2, Bill of Material Regulator PCB 2.5 Display PCB Figure 2.5.0, Schematic, Display PCB Figure 2.5.1, Assembly, Display PCB Table 2.5.2, Bill of Material, Display PCB 2.6 Processor/Sensor PCB Figure 2.6.0, Schematic, Processor/Sensor PCB (NOTE: Contact Sigma International for a full size schematic) Figure 2.6.1, Assembly, Processor/Sensor PCB Table 2.6.2, Bill of Material Processor/Sensor PCB 2.7 Motor Assembly Figure 2.7.1, Assembly, Motor Table 2.7.2, Bill of Material, Motor Assembly 2.8 Shaft Sensor Figure 2.8.1, Assembly, Shaft Sensor Table 2.8.2, Bill of Material, Shaft Sensor 2.9 Pole Clamp Figure 2.9.1, Assembly, Back Panel Table 2.9.2, Bill of Material, Back Panel Assembly 2.10 Pump Mechanism Figure 2.10.1, Assembly, Pump Table 2.10.2, Bill of Material, Pump Assembly 2.11 Rear Case Figure 2.11.1, Assembly, Rear Case Table 2.11.2, Bill of Material, Rear Case 2.12 Front Case Figure 2.12.1, Assembly, Front Case Table 2.12.2, Bill of Material, Front Case
SIGMA MODEL 8000 & 8000 Plus INFUSION PUMP - SERVICE MANUAL REV. M TABLE OF CONTENTS 2.13 Final Assembly/Labels Figure 2.13.1, Assembly, Final Table 2.13.2, Bill of Material, Final Assembly 2.14 Keyboard Figure 2.14.0, Schematic Figure 2.14.1, Assembly, 8000 Keyboard Figure 2.14.2, Assembly, 8000 Plus Keyboard 2.15 Assembly Pump Body/Motor Figure 2.15.1, Assembly, Pump Body/Motor Table 2.15.2, Bill of Material, Pump Body/Motor 2.16 Roller Clamp Figure 2.16.0, Schematic 2.17 Upstream Occlusion Sensor Figure 2.17.0, Schematic SECTION 3 THEORY OF OPERATION 3.1 Mechanical Components 3.1.1 Case 3.1.2 Back Panel/Pole Clamp Assembly 3.1.3 Tube Channel 3.1.3.1 Air/Upstream Occlusion Sensor 3.1.3.1.1 Upstream Air/Occlusion Detection 3.1.3.2 Roller Clamp Holder 3.1.3.2.1 Uncontrolled Flow Protection 3.1.3.2.2 Roller Clamp Sensing 3.1.3.3 Pump Assembly 3.1.3.3.1 Peristaltic Pump Fingers and Pressure Plate 3.1.3.4 Downstream Occlusion Sensor 3.1.3.4.1 Downstream Occlusion Sensing 3.1.3.5 Pressure Plate Release Lever 3.1.4 Stepper Motor and Drive Belt 3.1.4.1 Motor 3.1.4.2 Motor Driver 3.1.4.3 Stepper Motor control 3.2
Electronic Components 3.2.1 Functional Blocks 3.2.1.1 Block Diagram and Cable Diagram 3.2.2 Transformer PCB/AC Line Circuit 3.2.2.1 Line Cord 3.2.2.1.1 Line Cord and Input Voltage Selector 3.2.2.2 AC Inlet Module, Fuses 3.2.2.3 Power Transformer 3.2.2.4 Secondary Voltage and Power Indicator 3.2.3 Regulator PCB/Battery Circuit 3.2.3.1 Rectifier, Filter, Regulator 3.2.3.2 Logic Voltage Supply and Switch
SIGMA MODEL 8000 & 8000 Plus INFUSION PUMP - SERVICE MANUAL REV. M TABLE OF CONTENTS
3.2.4
3.2.5 3.2.6
3.2.7 3.2.8 3.2.9
3.2.3.3 Battery Charger 3.2.3.4 Battery Pack 3.2.3.5 Regulator PCB Display PCB/Auxiliary Bus 3.2.4.1 Display PCB 3.2.4.2 Display/Auxiliary Bus Interface 3.2.4.3 LED Displays Sensor PCB Processor PCB 3.2.6.1 Microprocessor 3.2.6.2 Power Switching Control 3.2.6.3 Static RAM and Program PROM 3.2.6.4 Electrically Erasable PROM 3.2.6.5 RTC Clock and Supervisor Circuit 3.2.6.6 Analog Input Channels 3.2.6.7 Pump Temperature Monitor 3.2.6.8 Speaker Driver/Volume Control 3.2.6.8.1 Speaker 3.2.6.9 Display/Auxiliary Interface Keyboard 3.2.7.1 Keyboard Interface Text Port, Shaft Sensor, Flow Sensor, Lever Lock Control Back Panel/Serial Interface Connector 3.2.9.1 Flow Sensor and Interface 3.2.9.2 Nurse Call 3.2.9.3 Serial Communication Interface
SERVICE MANUAL SIGMA INTERNATIONAL MODEL 8000 & 8000 Plus INFUSION PUMPS SECTION 1
SIGMA MODEL 8000 & 8000 Plus INFUSION PUMP - SERVICE MANUAL REV. M TABLE OF CONTENTS SECTION 1 GENERAL INFORMATION 1.1 Limited Warranty 1.2 Cautions and Warnings 1.3 Cleaning and Maintenance 1.4 Specifications 1.5 Preventive Maintenance 1.6 User Accessible Options 1.7 Biomedical Accessible Options 1.8 Troubleshooting Guide 1.9 Service
SIGMA MODEL 8000 & 8000 Plus INFUSION PUMP - SERVICE MANUAL REV. M 1.1 WARRANTY 1.1 MODEL 8000 INFUSION PUMP LIMITED WARRANTY SIGMA International warrants, to the original purchaser, the SIGMA 8000 Infusion Pump (hereinafter Pump) to be free from defects in material and workmanship under normal use and service for one year from the date of purchase. SIGMA's obligation under this limited warranty shall be limited to repair or replacement of Pumps, which, upon SIGMA's examination, are found defective in material or workmanship under normal use and service within one year from the date of purchase by the original purchaser. The repair or replacement of any Pump under this limited warranty shall not extend the term of this limited warranty beyond the original term as set forth in this paragraph. Qualified, trained service personnel must perform all repairs qualifying under this limited warranty. In the event that any Pump is found to be defective during the aforesaid warranty period, the purchaser shall notify SIGMA in writing of any claimed defect within thirty days after such claimed defect is discovered. The Pump claimed to be defective must then be promptly delivered to SIGMA or its designated representative for inspection and repair or replacement, if necessary. Pumps returned to SIGMA must be properly packaged and sent to SIGMA with postage and handling prepaid. Severe pump damage may result if SIGMA shipping cartons and inserts are not used. Shipping cartons and inserts are available from SIGMA. This limited warranty shall not apply to defective conditions or damage caused, in whole or in part, by negligence, fluid spills, dropped Pumps, misuse, abuse, improper installation, improper cleaning, alteration, or damage caused by improper shipment to SIGMA. If, after inspection, SIGMA is unable to identify a problem, SIGMA reserves the right to invoice the purchaser for such inspection. Annual Preventative Maintenance Inspections are also excluded from this warranty. THIS LIMITED WARRANTY IS THE SOLE AND ENTIRE WARRANTY PERTAINING TO THE PUMP AND IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES OF ANY NATURE WHATSOEVER WHETHER EXPRESS, IMPLIED OR ARISING BY OPERATION OF LAW, TRADE, USAGE OR COURSE OF DEALING, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE. ANY AFFIRMATION OF FACT OR PROMISE MADE BY SIGMA SHALL NOT BE DEEMED TO CREATE AN EXPRESS WARRANTY THAT THE PUMP SHALL CONFORM TO THE AFFIRMATION OR PROMISE; ANY DESCRIPTION OF THE PUMP IS FOR THE SOLE PURPOSE OF IDENTIFYING IT AND SHALL NOT BE DEEMED TO CREATE AN EXPRESS WARRANTY THAT THE PUMP SHALL CONFORM TO SUCH DESCRIPTION; ANY SAMPLE OR MODEL IS FOR ILLUSTRATIVE PURPOSES ONLY AND SHALL NOT BE DEEMED TO CREATE AN EXPRESS WARRANTY THAT THE PUMP SHALL CONFORM TO SUCH SAMPLE OR MODEL; AND NO AFFIRMATION, PROMISE, DESCRIPTION SAMPLE OR MODEL SHALL BE DEEMED TO BE PART OF THE PURCHASE OF THE PUMP. THE PURCHASER EXPRESSLY ACKNOWLEDGES THAT THIS LIMITED WARRANTY CONSTITUTES THE PURCHASERS SOLE AND EXCLUSIVE REMEDY WITH RESPECT TO ANY CLAIM OF THE PURCHASER ARISING OR RESULTING DIRECTLY OR INDIRECTLY FROM THE USE OF THE PUMP. IN NO EVENT SHALL SIGMA BE LIABLE HEREUNDER FOR AN AMOUNT THAT EXCEEDS THE PURCHASE PRICE OF THE PUMP. NO PERSON, FIRM OR CORPORATION IS AUTHORIZED TO ASSUME FOR SIGMA ANY LIABILITY IN CONNECTION WITH THE SALE OF THE PUMP.
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SIGMA MODEL 8000 & 8000 Plus INFUSION PUMP - SERVICE MANUAL REV. M 1.2 CAUTIONS AND WARNINGS 1.2 MODEL 8000 INFUSION PUMP DANGERS, WARNINGS AND CAUTIONS DANGER: −
RISK OF EXPLOSION IF USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS.
−
RISQUE D'EXPLOSION. NE PAS D’ANESTHESQUES INFLAMMABLES.
−
ELECTRIC SHOCK HAZARD. NO USER SERVICEABLE PARTS. DO NOT OPEN DEVICE COVER. REFER SERVICING TO QUALIFIED SERVICE PERSONNEL.
−
RISK OF FIRE. REPLACE FUSES AS MARKED.
−
ANY PUMP THAT HAS BEEN DROPPED OR IS OTHERWISE VISIBLY DAMAGED MUST NOT BE USED. Discontinue use immediately and refer to a qualified Service Technician for inspection and repair prior to further use.
−
USE ONLY I.V. ADMINISTRATION SETS THAT ARE LISTED ON SIGMA COMPATIBLE SET LISTING (contact SIGMA for listing). NOTE: Use of any other sets will result in malfunction or inaccurate delivery.
−
DO NOT USE IF ROOM OR PUMP TEMPERATURE IS BELOW 15°C (60°F) OR ABOVE 40°C (104°F).
−
LITHIUM BATTERY (SIGMA P/N 55003) (LOCATION: BT1 ON PCBA P/N 60010) DANGER OF EXPLOSION IF THE BATTERY IS INCORRECTLY REPLACED. REPLACE ONLY WITH THE SAME OR EQUIVALENT TYPE RECOMMENDED BY SIGMA. DISCARD USED BATTERIES ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS.
−
LITHIUM BATTERY (SIGMA P/N 55003) (LOCATION: BT1 ON PCBA P/N 60010) IL Y A DANGER D'EXPLOSION S'IL Y A REMPLACEMENT INCORRECT DE LA BATTERIE. REMPLACER UNIQUEMENT AVEC UNE BATTERIE DU MEME TYPE OU D'UN TYPE RECOMMANDE PAR SIGMA. METRE AU REBUT LES BATTERIES USAGEES CINFORMENT AUX INSTRUCTIONS DU FABRICANT.
−
Federal (USA) law restricts this device to sale by or on the order a physician or other licensed practitioner.
−
Operate only on the AC Line voltage for which the unit is marked.
−
Use only a Hospital Grade outlet for AC operation to assure proper grounding.
−
The pump should be plugged in during storage to maintain proper battery charge.
EMPLOYER
EN
PRESENCE
WARNING:
CAUTION:
ATTENTION:
CAUTION:
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SIGMA MODEL 8000 & 8000 Plus INFUSION PUMP - SERVICE MANUAL REV. M 1.2 CAUTIONS AND WARNINGS −
Remove AC power and disconnect the battery connector prior to servicing this Pump.
−
Routine cleaning and periodic maintenance is needed to assure that the Pump remains safe and functional. Refer to Section 1.3, Cleaning and Maintenance, and Section 1.5, Preventative Maintenance.
−
Solution spills should be cleaned up, as soon as possible, using a damp cloth or sponge. Dry thoroughly before use. The upstream sensors tube channel must be kept clean and dry at all times during pump operation. Do not use hard or sharp objects to clean sensor tube channel areas. Failure to comply with this requirement may cause the pump to fail. Refer to Section 1.3, Cleaning and Maintenance.
−
Static sensitive electronics used in SIGMA infusion pumps may be damaged by electrostatic discharge. Service technicians must follow proper ESDS procedures when working on units. Refer to MIL-STD-1686 for protective handling procedures.
−
Do not use a pen or any other sharp object to actuate the keyboard switches. Replace torn or punctured membranes immediately, to assure solutions won't internally damage the membrane switch and prevent proper operation of the Model 8000. (Replacement should only be performed by authorized personnel).
−
If using filter set, use only filters which state specifically in the instructions that they may be used with pumps. Read and follow instructions of the filter to be used.
CAUTION:
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SIGMA MODEL 8000 & 8000 Plus INFUSION PUMP - SERVICE MANUAL REV. M 1.3 CLEANING AND MAINTENANCE 1.3 MODEL 8000 CLEANING AND MAINTENANCE 1. CAUTION - Always press STOP then OFF and unplug the mains cord before cleaning. 2. CAUTION - DO NOT sterilize by autoclaving, ETO gas, or spraying. immerse any part of the pump. DO NOT use abrasive cleaners.
DO NOT
3. CAUTION – Do not use phenolic based cleaners or disinfectants, extended use may cause damage to the keyboard, case and any other plastic component of the Model 8000. 4. Clean exterior surfaces with pump in upright position. Apply cleaners with a dampened cloth per manufacture's instruction and dilution ratios. A lint free, foam-tipped swab (Chemtronics Foamtip (TM), for example) may be used in the Tube Channel. 5. Visually inspect the tubing channel and remove any foreign material. Blocked tube channel could cause accidental free flow. 6. Cleaning FLOW SENSORS (drop sensors): Clean FLOW SENSOR and PUMP FLOW SENSOR CONNECTOR with a small amount of isopropyl alcohol and a cotton swab. USE OF ELECTRICAL CONTACT CLEANERS WILL CAUSE DAMAGE TO THESE PARTS. 7. Subsequent disinfecting is recommended using the same application technique. Disinfectants should remain on the pump surface in an even, but not dripping, film for the manufactures' recommended contact time. Wipe dry or air-dry after completion of contact time period before pump reuse. 8. Dispose of all cleaning/ disinfectant materials per federal, state and local regulations for infectious waste disposal. 9. The following cleaners and disinfectants may be used: - 70% to 90% ethyl or isopropyl alcohol in water. * - 10% bleach in water (produces 0.55% Sodium Hypochlorite) - Sodium Hypochlorite cleaner disinfectant such as: - Dispatch TM ** by Caltech Industries, Inc (1-800-234-7700) * Alcohols are flammable and should be used in a well-ventilated area. ** The selection and use of disinfectants should be in accordance with hospital and user facility polices. This listing is strictly provided to indicate pump material compatibility with cleaning and disinfectant agents.
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SIGMA MODEL 8000 & 8000 Plus INFUSION PUMP - SERVICE MANUAL REV. M 1.4 PUMP SPECIFICATIONS 1.4 MODEL 8000 INFUSION PUMP SPECIFICATIONS 1.4.1 APPLICATIONS - Large and small volume parenterals - Neonatal - Homecare - Blood infusions and Epidural applications 1.4.2 ADMINISTRATION SET Compatible with standard gravity IV sets supplied by Hospira, Baxter and B.Braun/McGaw (all three are registered trademarks) and several other companies (consult SIGMA for a complete list of compatible standard IV sets and syringes). 1.4.3 PERFORMANCE When using IV bags or bottles*, flow rate accuracy is nominal ±5% from 2-999 ml/hr, and ±10% from 0.1-1.9 ml/hr. Flow rate accuracy for Securus AN tubing is 5% Accuracy 2 - 100 mL/hr, ± 6% Accuracy >100 - 400 mL/hr, ± 8% Accuracy >400 - 999 mL/hr. This is based upon; - Minus 100 mmHg maximum negative downstream pressure. - Plus 100 mmHg maximum positive downstream pressure. - With 72 hour usage of one section of an IV set, while infusing a maximum of 9 liters (i.e. 125 ml/hr). - With the solution 24 in. above the pumping mechanism. - Using the single standard IV set brand specified for the pump (approved Hospira, Baxter or B. Braun/McGaw sets). - Minimum 60-minute sample volumes (contact SIGMA for detailed trumpet curves). - Nominal temperature range from 68°F to 75°F. - Sets loaded taut with minimal stretch during loading (excessive set stretching can cause 10% flow errors). Note: If these parameters are exceeded, move to a fresh section of tubing to restore specified accuracy. -
0.1-999 ml/hr delivery range (RATE), with 0.1 ml/hr increments from 0.1-99.9 ml/hr and 1.0 ml/hr increments above 100 ml/hr. 0.1-9999 ml volume limit range.
*Note: IV bottle usage requires a vented IV set. KVO (keep vein open) rate is 1 ml/hr or the selected rate, whichever is lower. IV set based anti-free flow protection.
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SIGMA MODEL 8000 & 8000 Plus INFUSION PUMP - SERVICE MANUAL REV. M 1.4 PUMP SPECIFICATIONS Upstream occlusion time to alarm: DISTANCE OCCLUSION ABOVE PUMP RATE 5 ml/hr 100 ml/hr 999 ml/hr
6 IN. < 4 min. < 30 sec. < 10 sec.
24 IN. < 8.min < 40 sec. < 10 sec.
Note: Upstream occlusion detection is only effective for occlusions present immediately after the start of the pump’s run operation. Downstream occlusion time to alarm: With Occlusion 45 in. below the pump and alarm set to: RATE 1 ml/hr 100 ml/hr Max Bolus
2 PSI < 20 min. < 15 sec. 0.34 ml
10 PSI < 40 min. < 20 sec. 0.6 ml
15 PSI < 60 min. < 30 sec. 0.7 mil
Downstream occlusion time to alarm for Securus AN tubing: With Occlusion 45 in. below the pump and alarm set to: RATE 1 ml/hr 100 ml/hr Max Bolus
2 PSI < 20 min. < 15 sec. 0.34 ml
10 PSI < 80 min. < 30 sec. 0.7 ml
15 PSI < 110 min. < 30 sec. 0.8 mil
Occlusion pressure is adjustable from 2 - 15 PSI. Specifications for downstream occlusion are: Pressure setting Trip pressure tolerance 2 psi +2, -1 psi 3 to 4 psi +2, -1.5 psi 5 to 15 psi ±2 psi Mechanical occlusion pressure limit under fault conditions (the maximum pumping pressure if the occlusion alarm is inoperative) - 55 PSI. The air detector senses air bubbles > 1 inch long in the IV set. All safety related sensing systems are automatically checked for proper operation at power on and periodically thereafter. Faults are identified by FIX code. 1.4.4 TECHNICAL Type of pump - Volumetric infusion pump. Operating Principle - Linear peristaltic Rated voltage and current: 105-135 VAC (0.5A), 50/60 Hz, fused T500ma (IEC 127) - U.S. 220/240 VAC (0.25A), 50/60 Hz, fused T250ma (IEC 127) - European.
- Section 1, page 6 -
SIGMA MODEL 8000 & 8000 Plus INFUSION PUMP - SERVICE MANUAL REV. M 1.4 PUMP SPECIFICATIONS
Ground impedance <.13 ohms (per UL544 or CSA C22.2 No. 4) Patient leakage: < 25 microamps, normal condition; < 50 microamps, single fault condition. Electro magnetic compatibility immunity and emissions: st In compliance with IEC 601-1-2 and IEC 601-2-24 (1 edition 1993-04). Operating conditions: Relative humidity: 30-90% (non-condensing) Temperature: 65 - 85°F Atmospheric pressure: 22 - 31 in. Hg Battery: Type: 12-volt battery pack consisting of (6) 2V/2.5 amp hr rechargeable sealed lead acid batteries. *Operation: >4.5 hrs to LOW BATTERY indication, >30 min. from LOW BATTERY to PLUG IN alarm. Recharge time: >18 hrs * NOTE: Specification for batteries in “as new” condition. Computer interface: RS232 port on the back panel. This connector is also used to connect the pump to staff call systems. Since the systems pumps may be connected to vary widely, users should consult with SIGMA's Service Department for specific instructions. Users without sufficient electronic background and knowledge of both the SIGMA 8000 infusion pump and outside devices it may be connected to should never attempt such a connection. To do so otherwise can result in severe damage to the pump. Staff Call System Contact Closure: Rated Load 0.50A at 125VAC, 1A at 24VDC. Flow Sensor (Drop Sensor): The Flow Sensor detects drop flow in the IV set's drip chamber. The sensor fits on the drip chamber and its cord plugs into the pump's RS232 connector (back panel). When the sensor detects no drop flow, the EMPT BOTT/CLR ↑OCC (empty bottle/upstream occlusion) alarm occurs. Eliminating the cause of the alarm and pushing RUN causes the infusion to resume. Alarms: -
Air Downstream Occlusion Upstream Occlusion Infusion Complete Program Complete Low Battery/Plug In Malfunctions Empty Container (with optional flow sensor) Operator Errors/Prompts PM Due Notification
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SIGMA MODEL 8000 & 8000 Plus INFUSION PUMP - SERVICE MANUAL REV. M 1.4 PUMP SPECIFICATIONS
1.4.5 PHYSICAL Dimensions: - 9.5" H x 6.5" W x 6.75" D - (242 mm x 165 mm x 174 mm) Weight: - 10 lbs. (4.5 Kg) Case material: - High impact plastic (UL listed/CSA certified) IV Pole Clamp Pole Size Requirement - 0.5” to 1.0” diameter 1.4.6 LISTINGS & CERTIFICATIONS NRTL/C, to CSA Standard C22.2 No. 125-M1984, Electromedical Equipment and UL Standard No. 544, Medical and Dental Equipment. The "NRTL/C" indicates that the product has been evaluated by CSA to the applicable ANSI/UL and CSA Standards, for use in the U.S. and Canada. NRTL (Nationally Recognized Testing Laboratory) is a designation granted by the U.S. Occupational Safety and Health (OSHA) to laboratories, which have been recognized to perform certification to the U.S. Standards.
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SIGMA MODEL 8000 & 8000 Plus INFUSION PUMP - SERVICE MANUAL REV. M 1.5 PREVENTATIVE MAINTENANCE ITP 35001PM (Procedure revision level G) 1.0 PURPOSE The purpose of this procedure is to provide a guideline for the Preventative Maintenance of the SIGMA 8000 and 8002 IV pumps. This procedure may be used as an incoming check out procedure. 2.0 SCOPE The guidelines are to ensure that the SIGMA 8000/8002 IV pumps are operating within the specified parameters set forth by SIGMA International, Inc. 3.0 REFERENCES ICL 35001PM – Preventative maintenance check off sheet ICL 13000 – Field Procedure for Onboard Flow Calibration, Model 8000 IV Pump. 4.0 EQUIPMENT 4.1 SIGMA 8000 or 8002 Infusion Pump 4.2 IV set of the brand specified on the pump label NOTE: If the pump is being accuracy tested following a clinical problem, it is essential to test with an IV set of the same catalog number and lot number as that in use when the problem occurred. 4.3 IV container (250, 500 or 1000 ml), filled with water, to be used as pumping source. 4.4 Collection vessel to be class “A” 100 ml graduate (any 100ml collection vessel may be used if scale is used for flow rate accuracy measurement). 4.5 Pressure gauge 4.6 Line Safety Analyzer 4.7 Electronic balance with at least 0.01 gram precision. 4.8 Collection cup. 4.9 A cloth or paper towel. 5.0 DOCUMENTATION 5.1 After each operation in this procedure, record the findings on ICL 35001PM. 6.0 PROCEDURE NOTE: WHEN INSPECTING THE MODEL 8002, REPEAT STEPS 6.2 THRU 6.10 FOR BOTH CHANNELS, INDICATING THE CHANNEL INSPECTED ON ICL 35001PM. NOTE: The brand of IV sets being tested must be compatible with the pump under test. The proper IV set calibration is listed on the label located on the top of the pump. 6.1 PREVENTATIVE MAINTENANCE SCHEDULE 6.1.1 Preventative maintenance is recommended a minimum of once annually on all pumps in service. 6.1.2 Preventative maintenance should be performed after any user facility maintenance. 6.1.3 Preventative maintenance test should also be carried out whenever a pump is dropped, or suspected of having been otherwise damaged. 6.1.4 A PM DUE alarm may be set as indicated in section 6.15 of this procedure. 6.2 VISUAL INSPECTION 6.2.1 Inspect the pump for visual evidence of damage and or defects to exterior components (i.e. case, membrane and lever). 6.2.2 The IV set tube channel must be free of foreign materials and dry for both testing and use. 6.2.2.1 Any evidence of damage to these parts is reason to run the preventative maintenance checks. 6.2.3 Verify legibility of all labels.
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SIGMA MODEL 8000 & 8000 Plus INFUSION PUMP - SERVICE MANUAL REV. M 1.5 PREVENTATIVE MAINTENANCE ITP 35001PM (Procedure revision level G) 6.2.3.1 Replace labels as necessary. 6.3 VISUAL INSPECTION FOR MODEL 8002 ONLY 6.3.1 Inspect the both channels of the pump for visual evidence of pump body cracks: 6.3.1.1 Fully open the levers. 6.3.1.2 Observe the back walls of the tubing channels shown as hatched Area A and Area B on the Fig.1 (i.e. areas between roller clamp holders and lever assemblies) using directional light. Any evidence of cracks on these areas is reason to return the pump to the factory for service.
Fig.1 6.4 KEYBOARD TEST 6.4.1 The Model 8000 keyboard and displays may be checked for proper operation as follows: 6.4.1.1 Press the “ON/OFF” key to turn the unit on and observe that the displays indicate “8888 8888”. 6.4.1.2 Press the “RATE” (ML / H) key followed by the “1”, “2”, and “3” keys and observe the display to be “RATE 123”. 6.4.1.3 Press the “RATE” (ML / H) key followed by the “4”, “5” and “6” keys and observe the display to be “RATE 456”. 6.4.1.4 Press the “VOL LIMIT” key followed by the “7”, “8” and “9” keys and observe the display to be “VOL 789”. 6.4.1.5 Press the “VOL LIMIT” key followed by the “9”, “0”, and “.” keys and observe the display to be “VOL 90.0”. 6.4.1.6 Press the “VOL LIMIT” key followed by the “CLEAR” key and observe the display to be “VOL 0”. 6.4.1.7 Press the following keys and observe the associated displays: 6.4.1.7.1 “OPTIONS” key, display sequence is “SET” “OPTION CODE”, “9” key; display is “OPT 9”. 6.4.1.7.2 “9” key, display is “OPT 99” 6.4.1.7.3 “ENTER” key, display is “ALL CLEAR”, the pump will return to normal operation. 6.4.1.7.4 Prime a set and load the roller clamp (closed) into the pump. 6.4.1.7.5 Press the “OPEN” key and finish loading the set into the pump. 6.4.1.7.6 Set the rate to 999 and the volume to 1.0. 6.4.1.7.7 Press the “RUN / STOP” key, let the pump run to infusion complete.
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SIGMA MODEL 8000 & 8000 Plus INFUSION PUMP - SERVICE MANUAL REV. M 1.5 PREVENTATIVE MAINTENANCE ITP 35001PM (Procedure revision level G) 6.4.1.7.8 Press the “RUN / STOP” key to stop the pump. 6.4.1.7.9 Press the “TOTAL VOLUME” key; observe the display is “TOTL 1.0”. 6.5 UPSTREAM (PROXIMAL) OCCLUSION SENSOR TEST 6.5.1 Set rate to 100 ml / hr. 6.5.2 Set volume to 1 ml. 6.5.3 Occlude IV set 12” above the pump with a slide clamp or pair of hemostats. 6.5.4 Push the “RUN / STOP” key to start the pump. 6.5.5 Verify the pump goes into “CLR ↑ OCC / CLR AIR” alarm prior to infusion complete message. 6.6 AIR DETECTION TEST 6.6.1 Set volume limit to 50 ml. 6.6.2 Push the “RUN / STOP” key. 6.6.3 Introduce a 1 1/8’ air bubble upstream from the pump. 6.6.4 Verify the pump goes into “CLR AIR / CLR ↑ OCC” alarm. 6.7 DOWNSTREAM (DISTAL) OCCLUSION SENSOR TEST 6.7.1 Enter option 70 by pressing the “OPTION” key and “70”, and “ENTER”. 6.7.1.1 Verify the downstream occlusion trip pressure setting (if set to less than 15psi [750mmHg], set equal to 15psi [750mmHg]). 6.7.2 Record pressure setting 6.7.3 Set volume limit to 1 ml. 6.7.4 Connect a pressure gauge to the end of the IV set with a length of 4’ to 5’ of tubing between the pump and gauge. 6.7.5 Push the “RUN / STOP” key to start the pump. 6.7.6 Verify the pump goes into “CLR ↓ OCC” alarm at a pressure within +/- 2 psi or +/- 100 mmHg of the occlusion trip pressure setting. 6.7.7 If occlusion trip pressure setting was changed in step 6.7.1.1, then reset to PSI changed from using option 70. 6.8 MEMORY TEST 6.8.1 Turn the pump on. 6.8.2 Set a parameter for “RATE” and “VOL LIMIT”. 6.8.3 Turn the pump off. 6.8.4 Turn the pump on and verify the parameters were saved. 6.9 LOW FLOW RATE ACCURACY TEST FOR MODEL 8002 ONLY 6.9.1 Test should be done for both channels of the pump. 6.9.2 Materials required – See section 4.0 steps 4.1- 4.4, 4.7-4.9. 6.9.3 Test data – Flow rate (ml / hr) selected for test….….10 ml / hr. Pump vol. Limit (ml) (length of test)….…10 (1 hr.). Optimal actual volume pumped ..……...10 ml. Pass criteria: acceptable volumes……...9.5 – 10.5 ml. 6.9.4 A 1 hour warm up period, running with a tube installed, is recommended for the pumps before flow rate testing (Ref IEC601-2-24). 6.9.5 Hang the IV container, filled with water, 24” above the pumping mechanism. 6.9.6 Connect the IV set to the IV container and prime the set completely. 6.9.6.1 Remove all air from the tubing, being sure the drip chamber is at least half full. 6.9.7 Load a new / fresh section of the set into SIGMA 8002 pump and close the lever. 6.9.7.1 Open the roller clamp. 6.9.8 Place the open end of the IV set over a dry collection cup. 6.9.8.1 Be sure fluid is at the end of the IV set, but none has dripped into the collection cup before starting the test. 6.9.9 Turn the pump on, and set the flow rate = 10 ml / hr and set volume limit = 10 ml. 6.9.10 Begin the test by pressing the “RUN” key. 6.9.11 Allow the SIGMA 8002 pump to run until it goes into infusion complete alarm. 6.9.11.1 Press the “STOP” key to halt the KVO (keep vein open) rate once the pump goes into infusion complete. 6.9.11.2 If test is interrupted by any alarms, start this test again from the beginning.
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SIGMA MODEL 8000 & 8000 Plus INFUSION PUMP - SERVICE MANUAL REV. M 1.5 PREVENTATIVE MAINTENANCE ITP 35001PM (Procedure revision level G)
6.10
6.11
6.9.12 When delivery is complete, weigh the fluid using an electronic balance. 6.9.12.1 Weigh the collection cup with fluid in it. 6.9.12.2 Zero the electronic balance while fluid is in the cup. 6.9.12.3 Remove the collection cup. Empty the cup and dry the inside with a cloth or paper towel. 6.9.12.4 Weigh the empty cup. This value multiplied by negative one (-1) is the weight of the fluid collected. 6.9.13 If this weight is within the range 9.5 – 10.5 g, the pump is properly calibrated. Otherwise - return the pump to SIGMA International, Inc., or perform the flow rate calibration procedure according to CTP 13000 when flow rate error is not greater than 8% and repeat the Low Flow Rate Accuracy Test. RECOMMENDED FLOW RATE ACCURACY TEST 6.10.1 Materials required – See section 4.0 steps 4.1- 4.4. 6.10.2 Test data – Flow rate (ml / hr) selected for test ……….100 ml / hr. Collection vessel…………………...Class A Graduate, 100 ml. Pump vol. Limit (ml) (length of test)….…50 (30 min.). Optimal actual volume pumped (ml)…………...50 ml. Pass criteria: acceptable volumes……...47.5 – 52.5 ml. 6.10.3 A 1 hour warm up period, running with a tube installed, is recommended for the pumps before flow rate testing (Ref IEC601-2-24). 6.10.4 Hang the IV container 24” above the pumping mechanism 6.10.5 Connect the IV set to the IV container and prime the set completely. 6.10.5.1 Remove all air from the tubing, being sure the drip chamber is at least half full. 6.10.6 Load a new / fresh section of the set into SIGMA 8000 pump and close the lever 6.10.6.1 Open the roller clamp 6.10.7 Connect the end of the IV set to the collection vessel. 6.10.7.1 If the vessel is a 100 ml graduate, locate the end of the set around the 60ml level. 6.10.7.2 Be sure fluid is at the end of the IV set, but none has dripped into the graduate before starting the test. 6.10.8 Turn the pump on, and set the flow rate = 100 ml / hr and set volume limit = 50 ml. 6.10.9 Begin the test by pressing the “RUN” key. 6.10.10 Allow the SIGMA 8000 pump to run until it goes into infusion complete alarm. 6.10.10.1 Press the “STOP” key to halt the KVO (keep vein open) rate once the pump goes into infusion complete. 6.10.10.2 If test is interrupted by any alarms except air, the test can be continued as long as the pump was observed by the tester to have not been in “STOP” for more than ten minutes. 6.10.11 Observe the actual volume collected, either visually or weighed on the scale. 6.10.11.1 When measuring fluid level visually in the graduate, the level is read from the bottom of the fluid meniscus. 6.10.11.2 When measuring with the scale (gravimetric method): 6.10.11.2.1 Weigh the collection vessel and water. 6.10.11.2.2 Empty and dry the collection vessel. 6.10.11.2.3 Weigh the collection vessel. The difference between the two measured weights is equivalent to the volume delivered. 6.10.11.3 If the collection volume is within the range 47.5 – 52.5 ml, the pump is properly calibrated. 6.10.11.4 If not, return the pump to SIGMA International, Inc. for recalibration, or perform the flow rate calibration procedure according to CTP 13000 when flow rate error is not greater than 8%. LINE SAFETY ANALYSIS 6.11.1 Verify ground impedance is <0.13 ohms. 6.11.2 Verify chassis leakage current is <25 microamps.
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