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IVAC P 5000 MK2
User manual
126 pgs5.9 Mb0

Alaris IVAC P 5000 MK2 User manual

IVAC P5000 Mk II
Directions For Use Mode D’Emploi Gebrauchsanweisung
P5000 GB/FR/D
5001FAOPT71 ISSUE 8
SW V2R8
Contents
English
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Features of the IVAC P5000 Syringe Pump . . . . . . . . . . . . . . . . . 2
Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Operating Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 5
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Pole Clamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Replacing the Mains Fuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Loading a Syringe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Starting the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Front Panel and Main Display . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Purge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Clinician Over-Ride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
PCAM Patient History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
PCA Demands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Drug Infused . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
24 Hour Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
PCAM Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Pumping Pressure Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Maximum Dose Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
PCAM Patient Hand Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Using Pre-Set PCAM Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Alarm Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 - 16
Drug Names and Safety Limits . . . . . . . . . . . . . . . . . . . . . . . . . 17
General Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 - 20
Clock Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Pre-Set Protocol Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
RS232/Nurse Call Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Self Test Routine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Self Test Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24 - 25
Configuration Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Symbol Definition and Equipment Classification . . . . . . . . . . . . . 27
Syringe Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Compatible Extension Lines and Syringes . . . . . . . . . . . . . . . . . 28
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 - 31
Routine Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . 32
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Cleaning and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Battery Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Occlusion Pressure Limits for IVAC 50 ml Syringes . . . . . . . . . . . 34
Bolus Volume Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Spare Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Service Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Trumpet and Start-Up Curves . . . . . . . . . . . . . . . . . . . . . . . . 37 - 38
Service Contacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
5001FAOPT71 ISS 8.0 i / iv
Contenu
Français
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Fonctions de l’IVAC PCAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Boutons de commande et voyants lumineux . . . . . . . . . . . . . . . . 43
Précautions d’utilisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 - 45
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Noix de fixation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Remplacement des fusibles . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Installation de la seringue . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Démarrage de la pompe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Console et Menu Principal . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Purge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Bolus Manuel Dérogatoire . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Historique de la PCAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Demandes de PCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Médicament Perfusé . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Récapitulatif des dernières 24 heures . . . . . . . . . . . . . . . . . . . . 51
Registre des événements de la PCAM . . . . . . . . . . . . . . . . . . . . 51
Imprimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Icône de la Pression de Pompage . . . . . . . . . . . . . . . . . . . . . . . 53
Icône de la Dose Maximum . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Poignée de commande de la PCAM . . . . . . . . . . . . . . . . . . . . . . 53
Utilisation des protocoles pré-réglés . . . . . . . . . . . . . . . . . . . . . 54
Procédures d'alarme . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 - 56
Noms des médicaments et Limites de sécurité . . . . . . . . . . . . . . 57
Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 - 60
Programmation de l'horloge . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Protocole pré-réglé . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
RS232/ Appel de l'infirmière . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Procédures d'auto-test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Série d'auto-test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 - 65
Registre de configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Définition des symboles et Classification des matériaux . . . . . . . 67
Types de seringue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Prolongateurs et seringues compatibles . . . . . . . . . . . . . . . . . . 68
Caractéristiques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 - 71
Procédures de l'entretien de routine . . . . . . . . . . . . . . . . . . . . . 72
Destruction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Nettoyage et rangement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Fonctionnement de la batterie . . . . . . . . . . . . . . . . . . . . . . . . . 73
Limites de la pression d'occlusion pour les seringues IVAC de 50ml 74
Précision du volume du bolus . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Pièces Détachées . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Description technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Courbes en trompette / de démarrage . . . . . . . . . . . . . . . . . . 77 - 78
Centres d’Entretien . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Garantie . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
5001FAOPT71 ISS 8.0ii / iv
Inhalt
Deutsch
Bedienung Seite
Einführung . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Funktionen der IVAC PCAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Bedienelemente und Anzeigen . . . . . . . . . . . . . . . . . . . . . . . . . 83
Vorsichtsmaßnahmen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84 - 85
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Stativklemme . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Ersetzen der Sicherungen für den Wechselstromanschluß . . . . . . 86
Laden der Spritze . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Starten der Pumpe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Vorderseite und Hauptdisplay . . . . . . . . . . . . . . . . . . . . . . . . . 89
Füllen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Anwendereingriff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
PCAM Patientendatenspeicher . . . . . . . . . . . . . . . . . . . . . . . . . 90
PCA-Anforderungen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Infundiertes Medikament . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
24-Stunden-Aufzeichnung . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
PCAM Ereignisbericht . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Drucken . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Förderdrucksymbol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Symbol Maximaldosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
PCAM Patientenhandtaste . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Verwendung vorprogrammierter PCAM-Protokolle . . . . . . . . . . . 94
Vorgehen bei Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 - 96
Konfigurierte Optionen Seite
Medikamente und Förderbereiche . . . . . . . . . . . . . . . . . . . . . 97 - 98
Allgemeine Optionen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99 - 100
Uhrzeit einstellen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Programmieren der Protokolle . . . . . . . . . . . . . . . . . . . . . . . . . 102
Spezifikationen Seite
RS232/ Schwesternruf . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Selbsttestroutine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Selbsttestsequenz . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 - 105
Konfigurationsaufzeichnung . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Symboldefinition und Geräteklassifikation . . . . . . . . . . . . . . . . 107
Spritzenfabrikate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Kompatible Infusionsbestecke und Spritzen . . . . . . . . . . . . . . . 108
Spezifikationen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109 - 111
Routinewartung . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Entsorgung . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Reinigung und Lagerung . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Muster für P5000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Batteriebetrieb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Verschlußdruckgrenzen für IVAC 50-ml-Spritzen . . . . . . . . . . . . 114
Bolusvolumengenauigkeit . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Ersatzteile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Wartungsgeräte . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Technische Beschreibung . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Trompeten und Start-up-Kurven . . . . . . . . . . . . . . . . . . . . . 117 - 118
Service Kontaktadressen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Garantie . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
5001FAOPT71 ISS 8.0 iii / iv
Contents
5001FAOPT71 ISS 8.0iv / iv
Getting Started
Page
English
Getting Started 2 - 15 Configured Options 16 - 22 Specification 23 - 40
Français
Pour Démarrer 42 - 56 Options Configurées 57 - 62 Caractéristiques 63 - 80
Deutsch
Bedienung 82 - 96 Konfigurierte Optionen 97 - 102 Spezifikation 103 - 120
5001FAOPT71 ISS 8.0
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Getting Started
Introduction
The IVAC PCAM system allows a patient to maintain a consistent level of pain relief by providing self administration of a clinician-prescribed dose of analgesic as and when it is required. When the hand set is operated and the demand is within the parameters set by the clinician, the PCAM will automatically administer a precise bolus dose of analgesic. For enhanced monitoring and management of post operative acute pain within the hospital, the IVAC PCAM provides convenient Patient Controlled Analgesia (PCA) and detailed information at the bed-side about the patients use of PCA. Central to an effective pain service, PCAM promotes improved pain management, more effective use of nursing resources, better patient outcomes and can contribute towards a quicker discharge from hospital.
Features of IVAC PCAM
u User configured PCA protocols. u Comprehensive history. u Large graphics format display. u Two key positions providing separation of nursing
and programming procedures.
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u 5 pre-set hospital PCA protocols. u Unique electronic hand set with status indicator. u Communications and nurse call interfaces.
5001FAOPT71 ISS 8.0
MAIN DISPLAY - For screen information see Starting the Pump.
START Button - Press START button to commence PCAM operation. The GREEN light will illuminate when the pump is infusing.
STOP Button - Press to stop the infusion. The Amber light will flash to indicate an alarm.
Getting Started
Controls and Indicators
PURGE Button - Press both PURGE buttons simultaneously and hold down to purge the extension line during set up. PURGE will only operate when the cover is open and the key switch is in the RUN position.
PRINT Button - Press PRINT button to print patient history. A suitable printer must be connected.
BATTERY & AC POWER INDICATORS - Indicates when the unit is running from its internal battery or connected to the AC power supply with the battery being charged.
Use + and - arrow buttons to move cursor and increase/decrease values shown on the display during setup and configuration.
5001FAOPT71 ISS 8.0
HISTORY Button ­Press HISTORY button to display PCAM history graphs and event records.
ARROW Buttons - Use ARROW buttons in conjunction with prompts shown in the display.
KEY SWITCH - The KEY SWITCH turns the power ON/OFF and is used to select SET and RUN modes. Switching from RUN to SET modes without first pressing the STOP button will automatically stop the infusion.
3 / 120
Getting Started
Operating Precautions
This IVAC pump has been calibrated for use with single-use disposable syringes. To ensure correct and accurate operation, only use Luer­Lock versions of the syringe make specified on the pump or described in this Directions for Use. Use of non-specified syringes or administration sets may impair the operation of the pump and the accuracy of the infusion.
Uncontrolled flow or syphoning may result if the syringe is located on the pump without its finger grips and plunger correctly located in the slots provided, or if it is removed from the pump before the extension line is properly isolated from the patient. Isolation may include closing a tap in the patient line or activating a flow stop clamp.
When combining several apparatus and/or instruments with administration sets and other tubing, for example via a 3 way tap, the performance of the pump may be impacted and should be monitored closely.
Do not mount the pump in a vertical position with the AC power inlet or the syringe pointing upwards as this could affect electrical safety, in the event of a fluid spill over the unit or lead to an infusion of air which may be in the syringe. To protect against the introduction of air the user should regularly monitor the progress of the infusion, syringe, extension line and patient connections and follow the priming procedure specified herein.
This is a positive pressure device designed to achieve very accurate fluid administration by automatically compensating for resistance encountered in the infusion system.
The pumping pressure alarm system is not designed to provide protection against, or detection of, infiltration conditions which can occur at low pressures.
Several alarm conditions detected by this pump will stop the infusion and generate audible alarms. Users must perform regular checks to ensure that the infusion is progressing correctly and no alarms are operating.
4 / 120
5001FAOPT71 ISS 8.0
Getting Started
Operating Precautions
This instrument is protected against the effects of external interference, including high energy radio frequency emissions, magnetic fields and electrostatic discharge (for example, as generated by electrosurgical and cauterising equipment, large motors, portable radios, cellular telephones etc.) and is designed to fail safe if unreasonable levels of interference are encountered.
In some circumstances the unit may be affected by an electrostatic discharge of +/-8kV (contact), +/-15kV (air), at test levels lower than these values the unit will operate normally. In rare circumstances the unit may be affected by radiation at a level of 10V/m. If the unit is affected by this external interference the unit will fail safe or reset, ( a call back alarm will occur after 2 minutes). Should false alarm conditions be encountered either, remove the source of the interference, or regulate the infusion by another appropriate means.
5001FAOPT71 ISS 8.0
If this instrument is dropped, subjected to excessive moisture, humidity or high temperature, or otherwise suspected to have been damaged, remove it from service for inspection by a qualified service engineer.
An explosion hazard exists if the instrument is used in the presence of flammable anaesthetics. Exercise care to locate the unit away from any such hazardous sources. An electrical shock hazard exists if the units casing is opened or removed. Refer all servicing to qualified service personnel.
A comprehensive service manual containing circuit descriptions, servicing and testing information is available for this unit. It can be ordered from your ALARIS Medical Systems authorised distributor (Technical Service Manual Part Number 5000PB00004).
5 / 120
Getting Started
Installation
Check that the pump is complete, undamaged and that the voltage rating specified on the base plate is compatible with your AC power supply. Items supplied with this ALARIS Medical Systems syringe pump are;
u IVAC PCAM Mk II u POLE CLAMP u DIRECTIONS FOR USE u AC POWER CABLE (AS REQUESTED) u PROTECTIVE PACKAGING
Connect the unit to the AC power supply for 24 hours to ensure that the internal battery is fully charged. Should the pump fail to perform correctly, replace it in its original protective packaging and contact a qualified service engineer for investigation.
Pole Clamp
The pole clamp is supplied fitted to the rear of the unit and will provide secure fixing to standard I.V. poles of a diameter of up to 40mm. The pole clamp can also be fitted in a choice of 4 fixing positions allowing the unit to be mounted to vertical and horizontal poles, equipment rails and hospital furniture in a variety of convenient operating orientations. The pole clamp may be adjusted for use with horizontal fittings by using the existing fixings screws with the alternative fixing holes in the pole clamp. The pole clamp may also be secured to the base of the unit in a choice of four positions.
Do not mount the unit with the AC power inlet or the syringe pointing upwards. This could affect the electrical safety in the event of a fluid spill or lead to the infusion of air which may be in the syringe.
Important:
Replacing the Mains Fuses
If the pump continually illuminates the battery symbol and the AC power indicator light does not illuminate when the pump is connected to the AC power supply and switched ON, suspect that either, the power supply fuse in the AC power plug, or, the internal fuse has blown. First check the power supply fuse in the AC mains plug, if the AC power indicator light does not illuminate remove the pump from service. It is recommended that the mains fuses are only replaced by a qualified service engineer. For further information regarding the replacement of the internal fuses refer to the technical service manual.
6 / 120
5001FAOPT71 ISS 8.0
Getting Started
Loading a Syringe
Place the pump on a stable horizontal surface or secure using the pole clamp fitted. Prepare, load and prime the single use disposable syringe and extension line using standard aseptic techniques.
1. Squeeze the finger grips on the plunger holder and slide the mechanism to the left. Lift the syringe clamp and rotate to the left.
2. Insert the syringe into the slots on the plunger holder.
3. Squeeze the finger grips on the plunger holder and slide the mechanism to the right until the syringe finger flanges locates in the V slot.
Advance the syringe until the finger flanges touch the front of the V slot closest to the syringe clamp. This is important to prevent delay at the start of the infusion.
4. Rotate the syringe clamp forward until it locks onto the syringe barrel.
5. Check that the syringe plunger and finger flanges are correctly located in their slots.
Important: Only use a syringe of the type and size indicated in this manual. Using an incorrect syringe could adversely affect the accuracy of the infusion and the performance of the pump. When initially loading the syringe, allow for the volume of fluid contained in the extension line and retained in the syringe at the end of infusion as this “dead­space” will not be infused.
5001FAOPT71 ISS 8.0
Important:
7 / 120
Getting Started
Starting the Pump
1. AC POWER - Connect unit to AC power supply using the AC power cable.
2. SET - Insert PCAM key in front panel switch. Turn to SET position. The unit will automatically operate from its own internal rechargeable battery if it is switched ON without the AC power connected.
3. NEW PATIENT? - Answering NO will retain all previous patient history. YES will automatically reset the patient history to zero. Check time and date is correct and answer YES or NO.
4. SELECT/ MODIFY PROTOCOL - Carefully check the protocol displayed. If required, press MODIFY PROTOCOL to adjust the current protocol, or, NEXT PROTOCOL to select an alternative pre-set protocol.
5. RUN - Turn the PCAM key to the RUN position and remove from unit.
6. CHECK PROTOCOL - Carefully check that protocol is correct. Press OK.
7. CONFIRM SYRINGE - Check that the syringe type and size being used matches display. If required, the make of syringe can be changed by pressing the CHANGE TYPE button. Press OK.
8. PURGE (if required) - The PURGE buttons can only be used when the cover is open and the key switch is in the RUN position. When the purge operation is complete close the cover.
9. CONNECT PATIENT - Connect the PCA extension line to the patient access device. Recheck the protocol.
10.START - Press START to commence PCAM operation. PCA AVAILABLE will be displayed with the protocol summary, demand and drug totals. If selected, a loading dose will be delivered.
The unit will automatically operate from its internal battery if the pump is switched on without being connected to the AC power supply. Each time the unit is switched ON, check that the alarm beeps twice and that all the segments of the display, the green and amber lights are illuminated during the self test routine. The Key Switch should not be turned from OFF to SET whilst the syringe extension line is connected to the patient.
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Important:
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Getting Started
Front Panel and Main Display
Pump Status
Time
Demand
Status
Drug Infused
Current Protocol & Syringe Type
The PURGE button allows the delivery of a limited volume of fluid in order to purge the extension line prior to being connected to a patient.
1. PURGE can only be operated with the cover opened and the key switch in the RUN position.
2. Press the PURGE buttons together until fluid flows and priming of the syringe extension line is complete. The audible alarm will operate during use of the PURGE buttons and the volume used during priming will be shown in the volume infused display.
The purge feature is not activated when the cover is closed. Ensure that the extension line is disconnected from the patient before purging the line. No alarms are disabled during the operation of the purge feature.
Important:
Clinician Over-ride
The clinician over-ride feature can be used in RUN mode to administer an additional bolus dose or continuous background infusion of a limited dose and duration, for example during the PCA lock out period. The clinician over-ride is a special feature which can be configured according to the specific clinical situation. Clinician over­ride can also be used in SET mode to allow modification of the pre-set PCA Protocol when this option has been disabled for normal use.
1. Turn key to RUN position and ensure green light is illuminated on the STARTbutton.
2. Press and hold down the CLINICIAN OVER-RIDE button for 2 seconds.
3. Use “+” and “-” arrows and NEXT button to enter three figure pre-programmed clinician access code “n n n”. See technical service manual.
4. Select BOLUS or CONTINUOUS.
5. Use “+” and “-” arrows to select the dose delivered, when the correct value has been entered press
OK.
6. Use “+” and “-” arrows to select period over which the dose is to be delivered. Press OK when correct time has been entered.
7. BEGIN BOLUS? YES - Clinician bolus / continuous infusion will be delivered to the patient. NO - Quit set up and return to normal operation.
The delivery of the clinician over-ride continuous infusion will automatically halt while a Patient or Clinician over-ride bolus is being administrated. To cancel clinician over-ride during delivery, press STOP and press the YES softkey.
Important:
Pumping Pressure
Maximum Dose
Purge
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Getting Started
PCAM Patient History
Each time the PCAM unit is switched ON it will ask if this is a new patient. Pressing YES will provide opportunity to re-set patient history. Pressing NO continues with the current protocol and retains all protocol records, event history, graphs etc.
The PCAM will retain the events in a rolling memory. Following selection of a new patient, it remains possible in technician mode to access previous patient(s) history still held in memory.
Patient history can be accessed at any time by pressing the HISTORY button. PCAM provides a clear rolling 24 hour graphical representation of the PCA demand pattern and the drug administered to the patient. The graphs are updated when the history button is pressed and give values for each completed hour and the current hour.
PCA Demands
Provides a record of the last 24 hours good and failed PCA demands. The good demands are indicated by the shaded section of the graph and the failed demands by the clear section. The latest hour is shown at the right side of the display. This graph provides a clear picture of good and bad PCA demands and pattern of the patients usage. Used in conjunction with the PCA Demands graph, this display helps to indicate if the PCA protocol needs modification and when to end treatment.
1. To access the PCA demand graph press the HISTORY button once.
2. To exit the screen press the BACK softkey.
3. To scroll through to the next History screen press the HISTORY button.
Drug Infused
Record of the total amount of drug administered to the patient over the last 24 hours. The latest hour is shown at the right side of the display. This graph provides a clear picture of the actual drug administered, including loading dose, continuous background infusions, clinician over-rides and protocol changes. Used in conjunction with the PCA Demands graph, this display helps to indicate relative pattern of the demand pattern and the actual drug administered.
1. To access the PCA demand graph press the HISTORY button twice.
2. To return to the previous screen press the BACK softkey.
3. To scroll through to the next History screen press the HISTORY button.
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Getting Started
24 Hour Review
An hour by hour record of the last 24 hours, showing good and total PCA demands along with the total dose per hour. This information provides the accurate demand pattern and drug infused values from which the other graphs are derived.
1. To access the PCAM 24 Hour Review press the HISTORY button three times.
2. To return to the previous screen press the BACK softkey.
3. To scroll through to the next History screen
press the HISTORY button.
PCAM Event Log
Record of events since "NEW PATIENT" selected. Including, protocol selection and changes, patient demands etc. The event log will also record all alarms.
All events are recorded against date, clock and total drug infused.
1. To access the PCAM Event Log press the
HISTORY button four times.
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2. To return to the previous screen press the
BACK softkey.
3. To return to the Protocol Summary press
the HISTORY button again.
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Getting Started
Printing
A printer fitted with a serial interface (or cable with parallel to serial converter) can be connected to the PCAM unit, either during normal PCA operation, or, following use. Printing patient history provides a permanent record and can be used for analysis away from the bedside. All patient history, including protocols and the 24 hour demand pattern and drug dose administered graphs are available for printing. When connected to the printer, the PCAM can also be configured to provide line by line continuous printing of all events, patient demands etc. as they occur at the bedside. See General Options.
Continuous Mode
Enable Continuous printing by selecting YES in General Options.
1. Connect printer.
2. All events will be printed as they occur.
Protocol Summary - connect printer
1. Turn key to SET position.
2. Press PRINT button.
3. All protocol information will be printed with patient header.
Patient History - connect printer
1. Press PRINT button.
2. All protocol information, demand and drug totals, 24 hour graphs and records will be printed with patient header.
Event Log - connect printer
1. Press HISTORY button until event log is displayed.
2. Use ARROW buttons to position display at start point for events to be printed.
3. Press PRINT button.
4. All events will be printed from information on screen forward with time, date and patient header.
Event Log at New Patient - connect printer
1. Press PRINT button.
2. All events will be printed from the patient event log.
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Getting Started
Pumping Pressure Icon
The PUMPING PRESSURE ICON can be used to provide a constant visual indication of the current pumping pressure and the pressure level at which the alarm will operate. As the pressure required to administer the infusion increases, the box will be filled until the pressure reaches the alarm level. The pump will then stop infusing and the occlusion alarm will operate.
Maximum Dose Icon
The MAXIMUM DOSE ICON provides an indication of the amount of drug that has been administered during the limit period. The limit period is displayed alongside the bottle and the bottle fills up as doses are added to the mass infused. The bottle will appear to be full if the dose limit reaches the alarm level and the pump will then stop infusing. A message “Max Dose Limit” will be displayed and the icon will flash until dosing is less than the maximum dose limit. Clinician override is always available. Refer to GENERAL OPTIONS for instructions for displaying icons in the main display.
PCAM Patient Hand Set
The patient hand set supplied with the PCAM is designed to be ambidextrous and suitable for both adult and paediatric use. The hand set provides an indicator light which clearly shows when the PCAM is available and can be configured to flash when a PCA dose is being delivered.
The indicator on the patient hand set will reflect the configuration of the PCAM system and will provide feed-back on all, or just good demands, and the indicator light can be disabled should the clinical situation require.
Where appropriate the hand-set can be configured so that the patient will not need to refer to the instrument to assess if PCA is being delivered, or is available.
The hand set is provided with a clip for attaching it to bedding or clothing.
The PCAM concept is that the patient can be instructed in the use of the hand set as it will carry all the information required by the patient using PCA. This design simplifies patient instruction and encourages a smooth transfer to alternative devices used to treat long term chronic pain, should this be indicated.
A latching (but non locking) connector makes the hand set easy to fit. To remove, hold the body of the connector and pull away from the pump.
An alarm warning will operate if the hand set is disconnected from the unit while it is in operation or the hand set is connected to the unit with the PCA button depressed. In addition, the unit can be operated in continuous or clinician over-ride modes without the hand set connected, should this be indicated.
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Getting Started
Using Pre-Set PCAM Protocols
Operation of PCAM is greatly simplified by the use of PRE-SET PCA protocols. When the PCAM key switch is turned to the SET position the unit will automatically display pre-set PROTOCOL A if NEW PATIENT has been selected, or, display the previous protocol in use if NEW PATIENT has not been selected.
With the key switch in the SET position, it is possible for the user to modify the pre-set protocol using the MODIFY PROTOCOL button and select another pre-set protocol using the NEXT PROTOCOL button.
To modify a Pre-Set Protocol
1. Press MODIFY PROTOCOL indicated on
Drug ‘X’
the screen.
2. The protocol summary will be displayed. Use ARROWS to highlight a field, press ALTER to enter that field and “+”, “-” arrows to select desired values.
3. When field is correct press CONFIRM or CANCEL.
4. Display will show:
Protocol Drug name Drug ‘X’
A
Drug conc. 1.0mg/ml PCA Dose 1.0mg (1.0ml) Lockout period 5 mins Occlusion level 4 Continuous 0µg/h (0.0ml/h) Loading dose 0µg (0.0ml) Max. limit 50mg (50.0ml) Limit duration 4 hours PCA delivery STAT
5. Press OK to return to display.
(Note: A modified protocol has no pre-set letter).
To change to another pre-set protocol
Press NEXT PROTOCOL to display the step through the pre-set protocol. Pre-set protocols are identified as A to E. When the desired protocol has been selected it can be used by turning the key switch to the RUN position, or, can be modified using the MODIFY PROTOCOL.
To confirm protocol
When ever a new protocol is selected, modified or the key switch is turned to the SET position, the CONFIRM PROTOCOL display will appear. Pressing OK automatically records the protocol and any changes in the EVENT LOG history.
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Getting Started
Alarm Procedures
Alarms are indicated by a combination of an audible alarm, flashing amber STOP light and a descriptive message in the display.
1. A continuous audible alarm indicates that the infusion has stopped. First press MUTE to silence the alarm for a maximum of 2 minutes, then check the display for an alarm message. Press STOP to cancel the alarm message.
2. When the cause for the alarm has been rectified press START to restart operation.
Display Description
COVER OPENED DURING OPERATION
COVER OPENED
DRIVE DISENGAGED
The cover has been opened, or cover lock operated, during operation. Check cover and lock.
PUMP DRIVE DISENGAGED The drive system has been disengaged during
operation. Unlock and open the cover. Check the finger grips and the position of the syringe.
LINE OCCLUSION
SYRINGE ERROR
CHECK HANDSET
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EXCESSIVE PUMPING PRESSURE Pumping pressure has reached the alarm limit. Unlock
and open the cover, squeeze finger grips on the plunger holder to release the drive mechanism and relieve any excessive pressure in the syringe and patient line. Identify and remove the cause of the blockage in the drive, syringe, or administration system before restarting the infusion.
SYRINGE SIZE ERROR / FITTED INCORRECTLY Incorrect size of syringe has been fitted, the syringe
clamp has not been positioned correctly on the syringe or has been disturbed during operation or plunger is not fitted in plunger slot. Unlock and open the cover, check syringe size, position of syringe clamp, syringe and plunger.
PATIENT HAND SET FAILURE Patient hand set has become faulty or disconnected
during operation. Check operation and connection of the hand set to the unit. Press START to continue if operation without the hand set is required.
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Getting Started
Alarm Procedures
BATTERY CHARGE LOW WARNING Battery charge low with 30 minutes operation
remaining. Battery indicator will flash and after 30 minutes a continuous audible alarm will indicate that the battery is exhausted. Reconnect to AC power supply to continue operation and charge internal battery.
BATTERY EXHAUSTED Internal battery exhausted. To silence the alarm switch
the key switch to the OFF position and reconnect unit to AC power supply. Restart operation on AC power whilst charging the internal battery. Switch to the RUN position.
NEAR END OF SYRINGE WARNING Syringe almost empty with about 6% of its volume
remaining. Press START to silence alarm and continue operation. Display will flash SYRINGE NEAR EMPTY.
SYRINGE EMPTY - END OF INFUSION The pump has reached the end of the infusion. About
1% of the syringe volume will remain in the syringe helping to prevent the infusion of air bubbles into the PCA set.
DisplayDescription
BATTERY LOW
BATTERY EXHAUSTED
SYRINGE NEAR EMPTY
SYRINGE EMPTY
AC POWER SUPPLY DISCONNECTED WARNING AC Power has been disconnected and the pump is
operating on battery power. Reconnect AC power supply or press STOP to silence the alarm and continue battery operation. The display will light up ON BATTERY. The alarm will automatically cancel if the AC power supply is reconnected.
INTERNAL MALFUNCTION The alarm system has detected an internal malfunction.
Note the malfunction code. Remove unit from service for examination by a qualified service engineer.
AC POWER FAIL
MALFUNCTION
Alarm Procedures - Alarms without screen prompts Description
NURSE ATTENTION WARNING Unit left switched ON for over 2 minutes without
starting operation. Press STOP or any of the control buttons to silence the alarm for a further 2 minutes.
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3 BEEPS
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Configured Options
For technician access codes please refer to the Technical Service Manual.
Drug Names and Safety Limits
1. Turn key switch to SET position while pressing down START button.
2. Enter the access code using the rate selection arrows.
3. Select DRUG NAMES AND SAFETY LIMITS from the menu. Press ENTER.
4. Press MODIFY DRUG to modify the drug summary. Use “+” and “-” arrows to select desired values. When field is correct press OK to store the selection.
5. NAME: Use “+” and “-” arrows to set highlighted letter. Press NEXT for next character (up to ten letters). Press OK when complete.
6. MIN DRUG CONC: Use “+” and “-” arrows to set minimum concentration. Press OK when complete.
7. MAX DRUG CONC: Use “+” and “-” arrows to set maximum concentration. Press OK when complete.
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8. MIN LOCKOUT PERIOD: Use “+” and “-” arrows to set minimum lockout period. Press OK when complete.
9. MAX LOCKOUT PERIOD: Use “+” and “-” arrows to set maximum lockout period. Press OK when complete.
10.MIN PCA DOSE: Use “+” and “-” arrows to set minimum PCA dose. Press OK when complete.
11. MAX PCA DOSE: Use “+” and “-” arrows to set maximum PCA dose. Press OK when complete.
12.MAX CONTINUOUS: Use “+” and “-” to set maximum continuous rate. Press OK when complete.
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Configured Options
Drug Names and Safety Limits
13.MAX LOADING DOSE: Use “+” and “-” arrows to set maximum loading dose. Press OK when complete.
14.MAX DOSE LIMIT: Use “+” and “-” arrows to set maximum dose limit. Press OK when complete.
15.MAX CLINICIAN BOLUS: Use “+” and “-” arrows to set the maximum clinician bolus. Press OK when complete.
16.NEXT DRUG to display the next drug name and the safety limits. The five pre-set drug protocols are identified as 1 to 5.
17.Press QUIT to exit and return to configuration menu.
18.When set-up is complete, turn key switch to OFF position to save selection and to turn PCAM off.
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Configured Options
General Options
General options allow PCAM to be configured to suit the specific requirements of a particular clinical situation. The selected options should be recorded on the CONFIGURATION RECORD sheet for reference.
1. Turn key switch to SET position while pressing down START button.
2. Enter access code using the rate selection arrows.
3. Enter the first digit and press NEXT indicated on the screen.
4. When the complete code has been entered press ENTER.
5. Select GENERAL OPTIONS. Press
ENTER.
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6. Use "+" and "-" arrows to select values/options, press NEXT to move to the next option and QUIT to return to menu.
7. When set-up is complete, turn key switch to OFF position to save selection.
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Configured Options
General Options
The general options available are as follows:
1. ICONS on display YES - displays Pumping Pressure and Maximum Dose ICONS.
2. Protocols in use PCA pre-set protocols to be available. Select number from 1 to 5.
3. Modify protocol YES - allows protocols to be modified in SET mode.
4. Handset mode MODE A B C
5. Delayed call-back YES - call-back alarm can be delayed from 10 mins up to 90 mins.
6. Display Sleep YES - display goes blank after 2 minutes.
7. Chirp low alarms YES - "chirp" alarm during use on battery/near end.
8. Continuous infusions YES - Continuous infusions option in protocols.
9. Loading doses YES - Loading dose option appears in protocols. To activate this option "NEW
10. Max. dose limits YES - Dose limit option appears in protocols.
11. Variable dose rates YES - Variable dose rate option available.
12. Comms identity number Use arrows to set pump identity (between 000 and 127) for use with remote
13. Comms enabled YES - RS232 Communications enabled.
14. Nurse call YES - Nurse call connector enabled.
15. Nurse call inverted YES - Nurse call inverted enabled.
16. Continuous Print YES - Allows printing of events as they happen.
17. Default Syringe YES - Default syringe enabled.
18. Lock syringe type YES - Syringe type locked to default syringe.
19. Quiet mode YES - Quiet mode enabled.
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NO - ICONS disabled.
NO - removes modify protocol option in SET mode.
BEEP GOOD ALL ALL HAND SET LIGHT: PCAM STOPPED OFF OFF OFF PCA AVAILABLE ON ON ON PCA DELIVERING FLASH ON FLASH PCA LOCK-OUT OFF ON ON
NO - call-back will be cancelled for up to 2 mins or extended to 15 mins. To extend call-back alarms, press and hold the stop key for 4 seconds . This allows the time to be extended.
NO - display stays on during operation.
NO - no "chirp" alarm.
NO - Continuous infusions are not available.
PATIENT" is confirmed. The protocol also includes the loading dose. Start the PCA. NO - Loading doses are not available.
NO - Dose limits are not available.
NO - Loading doses are not available.
communications.
NO - RS232 Communications disabled.
NO - Nurse call connector disabled.
NO - Nurse call inverted disabled
NO - Continuous printing disabled.
NO - Default syringe disabled
NO - Syringe type not locked to default syringe.
NO - Quiet mode disabled.
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The internal clock is used to record patient history.
Configured Options
Clock Set
1. Turn key switch to SET position while pressing down START button.
2. Enter access code using the rate selection arrows.
3. Enter the first digit using the selection arrows and press NEXT indicated on the screen.
4. When the complete code has been entered press ENTER.
5. Select CLOCK SET from Menu. Press ENTER.
6. Display will show current date and time programmed into unit.
7. UP/DOWN ARROWS Use "+" and "-" arrows to change values in
the highlighted field. When entry is correct press NEXT to move highlight from left to right.
8. Press OK to save the date and time.
The internal clock is the reference against which the PCAM unit stores patient history and events. Changing the clock will automatically reset the dates against which all new patient history is stored in the unit and may effect the presentation of the history graphs Patient history should always be recorded and, if required, printed prior to changing the clock.
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Important:
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Configured Options
Pre-Set Protocol Set Up
Pre-set Drug names and safety limits apply to pre-set protocols during protocol selection and modification.
1. Turn key switch to SET position while pressing down START button.
2. Enter access code using rate selection arrows.
3. Enter first digit and press NEXT indicated on the screen.
4. When the complete code has been entered press ENTER.
5 Select PROTOCOL DEFAULT SET-UP
from the menu. Press ENTER.
6. Press MODIFY PROTOCOL to display current protocol summary. Use ARROWS to highlight a field, press ALTER to enter that field and "+" and "-" arrows to select desired values.
7. When field is correct press CONFIRM or CANCEL. Press OK to return to protocol summary.
Note:
One of the five drugs programmed in the Drug Names and Safety Limits are selectable for each protocol. Additionally a default drug with limits set to extremes may be chosen and is indicated by “ DRUG “.
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Specifications
RS232 / Nursecall Feature
The RS232 / Nursecall feature fitted to this IVAC “P” Series Syringe Pump allows the pump to be monitored remotely and/or controlled via a suitable central monitoring or computer system. When the pump is started by a command from the serial interface, communication must take place over the serial interface, a communication must take place every 15 seconds or the pump will alarm, display communications failure and stop infusing. This failure protects against failure of the communications, including the removal of the RS232 cable.
The nursecall interface provides a remote backup to the internal audible alarm. It should not be relied upon to replace monitoring of internal alarm. Refer to the technical service manual for further information regarding the RS232 interface. Since it is possible to control the syringe pump using the RS232 interface at some distance from the pump and hence remote from the patient, responsibility for the control of the pump is vested in the software run on the computer control system. The assessment for the suitability of any software used in the clinical environment to control or receive data from the pump lies with the user of the equipment. This software should include detection of the disconnection or other failure of the RS232 cable. The protocol is detailed in the technical service manual and is for general information only. This relates to IVAC “P” Series Syringe pumps fitted with the RS232 communication interface. Any connected analogue and digital components are required to meet EN60950 for data processing and EN60601 for medical devices. Anyone connecting additional devices to the signal input or output is a system configurator and responsible for meeting the requirements of the system standard EN60601-1-1.
Important:
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Specifications
Self Test Routine
The self test routine is designed to allow confirmation of many of the pump functions, defaults and calibrations without requiring internal inspection. It does not represent a full calibration check.
1. Turn key switch from OFF to SET while holding down the START button.
2. Enter “1 2 3” using the “+” , “-” and NEXT buttons.
3. Press ENTER to commence self test sequence.
4. The unit will now proceed through a series of tests as described below.
5. Press NEXT button to move to next test.
Should the pump fail the test sequence, it should be taken out of service and
Important:
inspected by a qualified service engineer.
Self Test Sequence
Display
1. SOFTWARE
REVIEW
2. SYRINGE REVIEW
3. -:- - v
4. “BEEP”
5.
6. Press S1
Test Description
SOFTWARE/SET UP REVIEW: Including software version, program crc, language, communications fitted.
REVIEW SET UP OF SYRINGE CALIBRATION DATA: Including syringe calibration, occlusion calibration and syringe range.
INTERNAL PSU VOLTAGE:
AUDIBLE ALARM TEST: Check alarm sound continuously.
DISPLAY AND BACKLIGHT DIM TEST: Check that all the display is
operating and that the display operates on a full backlight for the first part of the test, dims for the second and then switches off at the end of the test.
TOUCH PANEL SWITCH TEST: Press buttons in turn from S1 to S10 form START to PURGE until end of test is reached.
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