Deltech Fitness 6 1 0 1 manuale d’uso

33 T E C H N I C A L M A N U A L C A D D - P r i z m ® A M B U L A T O R Y I N F U S I O N P U M P MODEL 6101 Deltec MODEL 6100 This online version diff er s fr om the printed version. Certain information that is not intended f or patients has been removed.[...]

32 For detailed instructions, specifications, warnings, warranties and additional information on operat- ing CADD ® pumps, please refer to the Operator ’ s Manual supplied with the product. If you have additional comments or questions concerning the operation of CADD ® pumps, please call this num- ber: (800) 426-2448 . Our staff is available to[...]

34 T able of Contents 1. Introduction ............................................. 1 Limited Warranty ........................................... 1 Exposure to Radiation or Magnetic Resonance Imaging (MRI) ............................................... 1 2. CADD-Prizm ® Pump ................................ 2 Delivery Modes .....................[...]

1 1 Introduction The T echnical Manual is intended to provide a basic, but limited, understanding of the mechanical and electrical operation of the Deltec CADD-Prizm ® Computerized Ambulatory Drug Delivery pump to persons familiar with this device. The CADD-Prizm ® Operator’ s Manual should be used in conjunction with this publication for compl[...]

2 Pantone 653 Dk Blue Pantone 654 Extra Dk Pantone 519 Purple NO AIR DETECTOR INSTALLED ST ART STOP Y N LOCK DOSE NEXT ENTER OPTIONS ? Power Data In/Out 2 CADD-Prizm ® Pump Figure 1. Front and back views of the CADD-Prizm ® pump. Indicator Lights Amber Green Display Keypad Power Jack Data In/ Out Jack Air Detector Port Cover Air Detector (optiona[...]

3 Figure 2. PCA mode delivery profile. Clinician Bolus (used here as a loading dose) Demand Doses Continuous Rate Time Dosage Figure 3. Continuous mode delivery profile. Figure 4. Intermittent mode delivery profile. Figure 5. TPN mode delivery profile. PCA Delivery Profile The PCA (patient-controlled analgesia) delivery mode is used for therapies t[...]

4 Concentration Demand Dose Clinician Bolus mg/ml increment max. increment max. 0.1 0.01 0.99 0.01 2 0.2 0.02 1.98 0.02 4 0.3 0.03 2.97 0.03 6 0.4 0.04 3.96 0.04 8 0.5 0.05 4.95 0.05 10 1 0.05 9.9 0.05 20 2 0.10 19.8 1.10 40 3 0.15 29.7 1.15 60 4 0.20 39.6 0.20 80 5 0.25 49.5 0.25 100 10 0.50 99.0 0.50 200 15 0.75 148.5 0.75 300 20 1.00 198.0 1.00 [...]

5 Specifications (Nominal) General Pump Specifications Resolution Medicaton Cassette reservoir or CADD ® administration set, 0.050 ml/pump stroke nominal CADD-Prizm ® high volume administration set, 0.100 ml/pump stroke nominal Size 4.4 cm x 10.4 cm x 14.1 cm (1.7 in. x 4.1 in. x 5.6 in.) excluding cassette or other accessories W eight 568 g (20 [...]

6 Given 0 to 99999.99 in 0.01 unit increments Clinician Bolus 0.1 ml to 20.00 ml (or mg or mcg equiva- lent) (See T ables 2, 3 and 4 for scroll ranges) Delivery rate (Continuous Rate + Clinician Bolus): 125 ml/hr nominal Continuous Delivery Mode Specifications Reservoir V olume 1 to 9999 or Not In Use; programmable in 1 ml increments, displayed in [...]

7 Options Specifications Immediate T aper -Down (TPN) 0 to time remaining in the infusion period, in 10 minute increments (defaults to the currently programmed T aper -Down) AutoLock Not In Use, LL1 or LL2 T ime 00:00 to 23:59 Air Detector T urned On or T urned Off Event Log 0 to 500 events Extended History Up to 48 hours in 1 hour increments Biome[...]

8 Battery Compatibility Recommended Batteries Nine-volt alkaline or lithium batteries are recommended for use in the CADD-Prizm ® pump. Carbon-zinc, mercury , nickel-cadmium, or zinc-air 9-volt batteries should not be used. Battery Life The CADD-Prizm ® pump has been designed to provide optimal battery life. The expected battery life in the CADD-[...]

9 Rate Life Volume 0.4 ml/hr 120 hrs 48 ml 10 ml/hr 86 hrs 860 ml 30 ml/hr 37 hrs 1110 ml 50 ml/hr 26 hrs 1300 ml 100 ml/hr 13 hrs 1300 ml 200 ml/hr 14 hrs 2800 ml 350 ml/hr 7 hrs 2450 ml Rate Life Volume 0.4 ml/hr 212 hrs 85 ml 10 ml/hr 161 hrs 1610 ml 30 ml/hr 79 hrs 2370 ml 50 ml/hr 60 hrs 3000 ml 100 ml/hr 30 hrs 3000 ml 200 ml/hr 32 hrs 6400 m[...]

10 Intermittent Delivery Battery Life Note: Results are without air detector . TPN Delivery Battery Life Note: Results are without air detector . Volume Duration Cycle KVO Life Volume 23.5 1:00 hr 5:00 hr 0.2 ml/hr 117 hrs 477 ml 61 1:00 hr 6:00 hr 0.2 ml/hr 71 hrs 733 ml 125 1:00 hr 6:00 hr 0.2 ml/hr 38 hrs 798 ml 200 1:00 hr 12:00 hr 0.2 ml/hr 84[...]

11 4 Construction The pump ’ s housing is made of a special high impact plastic designed to reduce interference from electromagnetic fields and to dissipate electrostatic discharge. It is composed of two sections: the base and cover housing. The pump housing is sealed to ensure that the pump is water resistant. The battery compart- ment is not wa[...]

12 5 Theory of Operation Keyboard Circuitry The CADD-Prizm ® pump is controlled by a microprocessor . The actions of the micropro- cessor are controlled by a program, which is contained in the memory . Commands are issued to the microprocessor from the user via the nine keys on the key- board and the Remote Dose cord. The keys on the keyboard feed[...]

13 LED Status Indicators An amber and a green Light Emitting Diode (LED) are provided under the pump ’ s front panel overlay to provide pump status to the user . Under software control, the LEDs can either flash at a low duty cycle or be on con- tinuously . A flashing indicator typically indi- cates a normal mode of operation and a steady “ on [...]

14 detector . An infrared light source is mounted so that its light beam illuminates the infrared detector . An opaque flag is mounted concentri- cally to the camshaft and rotates with it be- tween the infrared light source and detector . When the flag interrupts the light beam, the output of the detector is sensed by the micro- processor via an in[...]

15 When the microprocessor commands the mecha- nism to pump, the camshaft begins to rotate, thus controlling the following pump cycle: 1. The inlet valve closes. 2. In synchrony with the expulsor moving down to compress the tubing, the outlet valve opens, expelling 0.050 ml of fluid (or 0.100 ml of fluid with a CADD-Prizm ® high volume administrat[...]

16 Air Detector The air detector is designed to detect air in the outlet tubing fluid path. The air detector is detachable if not needed. The CADD-Prizm ® pump automatically detects the presence of the air detector and will automatically turn the sensor on when powered up in LL0. When the optional air detector is installed, the Biomed T oolbox fea[...]

17 6 Safety Features and Fault Detection Hardware Safety Features Key hardware safety features include a watch- dog timer circuit, motor driver and motor watchdog circuits, cassette ‘ type ’ sensor circuit, latch/lock sensor circuit, and a voltage detector circuit. Each safety circuit performs a unique function to insure the overall safety of t[...]

18 Motor Driver/Motor W atchdog Circuit Motor drive circuitry is composed of a series of power FET transistors, passive components, and two voltage comparators. Built into the motor drive circuitry is an RC timer which times how long the motor runs each time it is turned on. If the motor runs for more than an average of 4 seconds, the circuit will [...]

19 Software Safety Features Hardware-related Software Safety Features Program Memory Check At power up and at regular intervals thereafter , the program memory is tested by calculating a Cyclic Redundancy Code (CRC) on the program and then comparing it with the CRC stored with the program. If the stored and calculated CRCs do not match, the softwar[...]

20 Overview If the CADD-Prizm ® pump displays an error code, a hardware or software fault has been detected by the microprocessor , and the pump should be returned for servicing. When hardware or software faults are detected by the microprocessor , pump operation stops and a continuous, audible alarm will be acti- vated as well as the amber warnin[...]

21 8 Cleaning and Inspection Procedures Use any of the following solutions to clean the pump and accessories: • Soap solution • Benzalkonium chloride concentrate (0.13%) • Glutaral concentrate, USP (2%) • 10 percent solution of household bleach (one part household bleach to nine parts water) • Alcohol, USP (93%) • Isopropyl Alcohol, USP[...]

22 Mechanical Inspection • Press each key on the keyboard. Each key should have a distinctive dome feeling. The keys should not feel flat. • Attach the battery door . The battery door should fit snugly in place when it is closed on the pump. • Attach either a 50- or 100-ml Medication Cassette reservoir or a CADD ® administra- tion set to the[...]

23 • Lock the device by inserting a key into the lock and turning counterclockwise until the mark lines up with the solid dot. The display should show “ Cassette Locked. ” • Unlock the device by inserting a key into the lock and turning clockwise until the mark lines up with the open dot. The display should show “ Cassette Unlocked. ” ?[...]

24 • Remove the 50- or 100-ml reservoir and attach a CADD ® administration set to the pump. Latch the cassette to the pump. The display should show “ Admin Set Latched. ” • Lock the device by inserting a key into the lock and turning counterclockwise until the mark lines up with the solid dot. The display should show “ Cassette Locked. ?[...]

25 NOTE: The remaining testing procedures should be performed using a 50- or 100-ml Medication Cassette reservoir containing fluid and a primed extension set with anti-siphon valve or a primed CADD ® administration set with anti-siphon valve. Starting/Stopping the Pump • Check the STOP/ST ART key by pressing it. “ Start the Pump? ” should be[...]

26 • Press the ENTER key . The display should now show 0/0. MG GIVEN Mode Check • Press the NEXT key to advance to the Milligrams Given screen. The display should now show 2.0 mg, if the DOSE key and Remote Dose cord were tested. If only the DOSE key was tested, the display will show 1.0. (If the above steps have not been followed exactly , dif[...]

27 NOTE: The pressure from the source must be zero when the cassette is attached. 3. Assemble the apparatus as shown in Figure 9. 4. Connect the Medication Cassette ™ reser - voir outlet tube to the metered pressure source. NOTE: Do not use a CADD ® extension set with anti-siphon valve. 5. Start the pump and run at 30 ml/hr . 6. Slowly increase [...]

28 Procedure 1. Spike an appropriate standard I.V . bag. 2. Prime the entire fluid path. 3. Program the pump to deliver a continuous rate of 20 ml/hr . 4. Start the pump. 5. Clamp the tubing halfway between the fluid reservoir and the pump. 6. The pump should alarm within three activa- tions after clamping the tubing. Note: Make sure the upstream o[...]

29 11. If the accuracy error percentage is greater than ± 6%, repeat the test with a new reservoir . If the pump fails a second time, call Deltec ’ s Customer Service Department. EXAMPLE: Predelivery Weight: 61.1 g Postdelivery Weight: - 41.6 g Weight of Amount Delivered: 19.5 g = 19.5 ml Volume of Amount Delivered: 19.5 ml Intended Delivery Vol[...]

30 Intended Actual Inaccuracy Accuracy Accuracy Delivery Delivery V olume Error Error Percentage V olume V olume 20 ml 19.5 ml -0.5 ml -0.5/20.0 ml =-0.025 -0.025 x 100 = ± 2.5% Table 15. Volumetric percentage calculation delivery volume. This is the inaccuracy volume . 8. Divide the inaccuracy volume by the intended delivery volume and multiply b[...]

31 CADD-Prizm ® Pump Cleaning and Functional T esting Checklist The following checklist is provided as a guide only to assist in establishing documentation of cleaning and functional testing for the CADD-Prizm ® pump. If service is provided, fill out this sheet and return it with the device. Serial # _________________ Reference Number ___________[...]

35 ISO 9001 Registered CADD, CADD-Prizm and Medication Cassette reservoir design are Deltec, Inc. trademarks. DURACELL is a DURACELL Inc. trademark. ULTRALIFE is a ULTRALIFE Batteries, Inc. trademark. LEMO is a LEMO USA INC. trademark. SaniCloth is a PDI trademark. The products described are covered by one or more of the following U.S. Patent Nos.,[...]