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Hospira 20678-04, Руководство по эксплуатации

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Plum A+

® 

Infusion Systems

System Operating Manual

19

operation of a sensor or microcomputer might be disrupted. 
Even in this event, the outcome would likely be a false alarm 
or detected system malfunction and would not result in a 
hazard to patient or operator.

• This equipment has been tested and found to comply with the 

EMC limits for the Medical Device Directive 93/42/EEC (EN 
55011 Class B and IEC/EN 60601-1-2:2001). These limits 
are designed to provide reasonable protection against 
harmful interference in a typical medical installation. The 
equipment generates, uses and can radiate radio frequency 
energy and, if not installed and used in accordance with the 
instructions, may cause harmful interference to other devices 
in the vicinity. However, there is no guarantee that 
interference will not occur in a particular installation. If this 
equipment does cause harmful interference with other 
devices, which can be determined by turning the equipment 
off and on, the user is encouraged to try to correct the 
interference by one or more of the following measures:

• Reorient or relocate the receiving device

• Increase the separation between the equipment

• Connect the equipment into an outlet on a circuit 

different from that to which the other device(s) is 
connected

• Consult the manufacturer or field service technician for 

help

• Portable and mobile RF communications equipment, such as 

cellular telephones, 2-way radios, Bluetooth devices, 
microwave ovens, in close proximity to this device may affect 
wireless and wired communications with the Infusion pump 
and/or the operation of the Infusion pump. Special 
precautions need to be exercised regarding EMC, These 
include:

• Use of a shielded Ethernet cable (CAT5 STP or better) 

for plugging into the RJ45 Ethernet connector. Using 
an unshielded Ethernet cable may result in increased 
emissions.

430-95597-004.book  Page 19  Friday, March 9, 2007  8:30 AM

Содержание 20678-04

Страница 1: ...430 95597 004 B Rev 04 2007 HOSPIRA INC LAKE FOREST IL 60045 USA ...

Страница 2: ... apply to both the Plum A Infuser and Plum A 3 Infuser unless otherwise noted Plum A Infuser List 20679 20792 04 NOTE This operating manual may also be used with Device List 12391 04 11971 04 when used with Module List 20677 04 Plum A 3 Infuser List 20678 04 CAUTION TH I S DEVICE IS TO BE USED WITH AN IV POLE WITH A 6 WHEEL BASE AND A SHELF ...

Страница 3: ...be used in most areas of patient care including but not limited to Product Description Each system includes a pumping module hereafter called the infuser and an assortment of disposable IV sets hereafter called a set optional accessories and this operator s manual The Plum A host device contains a Connectivity Engine peripheral module that provides wired Ethernet and wireless 802 11 a b g local ar...

Страница 4: ...r your local representative Indications for Use USER QUALIFICATION The Plum A is intended for use at the direction or under the supervision of licensed physicians or certified healthcare professionals who are trained in the use of the infuser and the administration of parenteral enteral and epidural fluids and drugs and whole blood or red blood cell components The training should emphasize prevent...

Страница 5: ...SERVED AT ALL TIMES FAILURE TO OBSERVE A WARNING MESSAGE IS POTENTIALLY LIFE THREATENING CONVENTION APPLICATION EXAMPLE Italic Reference to a section figure or table Function or mode specific instructions See Figure 3 1 Priming Cassette Primary Only Attach an empty container BRACKETED ALL CAPS Keys or buttons on the device are displayed in BRACKETED ALL CAPS or with a graphic START or Italic Softk...

Страница 6: ... Therefore figures may not exactly reflect the product Precautions The Plum A has been designed and manufactured to be safe reliable and easy to use This section details precautions and possible hazards For safe operation of the Plum A observe the following precautions and hazards HEALTHCARE PROFESSIONALS AND PATIENT RELATED In vitro studies have suggested that packed red blood cells with unusuall...

Страница 7: ...efore disconnecting a syringe from the cassette pull up the plunger slightly to avoid spilling the fluid For rigid containers close the upper slide clamp open the cassette door then remove and invert the cassette ports down Air bubbles may form distal to the cassette as result of normal outgassing of dissolved air in the fluid This may occur if chilled solution is in use if the infuser is mounted ...

Страница 8: ...r infusion should be no faster than ten times the critical drug s rate Dopamine for example delivered at 3 5 ml hr should not be accompanied by an infusion programmed any faster than 35 mL hr If the critical drug with half life less than 6 minutes is to be infused at 5 1 mL hr or greater the other infusion can be programmed at any desired rate NOTE The total of the primary rate plus the secondary ...

Страница 9: ...de anesthesia or analgesia for periods up to 96 hours This device can be used to administer only those anesthetics analgesics approved for epidural administration as indicated or allowed by the drugs FDA approved labeling Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient For epidural administration the use of Hospira catheter...

Страница 10: ...volume of fluid is administered over a short time period the pressure will take longer to return to normal If overdelivery occurs during administration observe the patient closely for signs of spinal cord compression disorientation headache transient neuralgias and drug overdose BATTERY OPERATION When the battery is removed from the Plum A do not operate on patients Use of a properly maintained an...

Страница 11: ...c Use syringe adapter List 11986 48 when using syringes smaller than 10 cc Some 10 cc syringes may require use of a syringe adapter Syringes larger than 10 cc may be attached directly to the secondary port of the cassette Use of a syringe adapter may decrease the occurrence of proximal occlusion alarms Use a 19 gauge or larger needle or catheter at the venipuncture site for viscous fluids if opera...

Страница 12: ...wly degrade components made from some plastic materials Using abrasive cleaners or cleaning solutions not recommended by Hospira may result in product damage Do not use compounds containing combinations of isopropyl alcohol and dimethyl benzyl ammonium chloride Never use sharp objects such as fingernails paper clips or needles to clean any part of the infuser Do not sterilize by heat steam ethylen...

Страница 13: ...d EEG machines These artifacts vary at a rate that is associated with the infusion rate If the monitoring machine is not operating correctly or has loose or defective connections to its sensing electrodes these artifacts may be accentuated so as to simulate actual physiological signals To determine if the abnormality in the monitoring equipment is caused by the infusion device instead of some othe...

Страница 14: ...ular installation If this equipment does cause harmful interference with other devices which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving device Increase the separation between the equipment Connect the equipment into an outlet on a circuit different from t...

Страница 15: ...ith the system standard IEC 60601 1 1 Any person who connects additional equipment to the signal input or output part configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of the system Standard IEC 60601 1 1 If in doubt consult the technical service department or your local representative Guidance on EMC Compatibility There is a share...

Страница 16: ... adjacent to or stacked with other equipment monitor the devices to verify normal operation USE ONLY components specifically labeled for use with the Plum A Infusion System to help ensure the device operates as intended If you suspect external RF sources or other equipment are influencing device operation contact the biomedical engineering department for additional guidelines concerning electromag...

Страница 17: ...nerates uses and can radiate radio frequency energy If not installed and used in accordance with the instructions it may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off ...

Страница 18: ...sional September 1999 The radiated output power of this Wireless LAN device is far below the FCC radio frequency exposure limits The Wireless LAN device for both Plum A and Plum A 3 has been evaluated with 0 2 inches separation of human body from the antenna and found to be compliant with FCC RF exposure limits WIRELESS DEVICE PRECAUTION The wireless 801 11a b g device usage in the 5150 5250 MHz b...

Страница 19: ...le clamp barcode wand holder and power cord Weight Plum A Approximately 9 5 lbs with battery Plum A 3 Approximately 28 lbs with 3 batteries Casing High impact plastic Power Requirements Plum A 120 V 50 60 Hz 35 VA Meets UL 60601 1 Plum A 3 120 V 50 60 Hz 120 VA Fuses F1 F2 250V 0 5 A internal Power Cord Hospital grade AC cord 10 ft long with transparent plug and retainer plate Battery Plum A One s...

Страница 20: ...IEC 60601 1 standard Medical Electronic Equipment Part 1 General Requirements for Safety NURSE CALL System Circuitry Ratings NURSE CALL alarm is factory set for Normally Open NO Contact the Technical Services Center to make an internal adjustment to change the device from Normally Open NO to Normally Closed NC system Voltage 30 VDC Max Current 0 25 Amps Max Contact Rating 3 Watts Max Device Name H...

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