RequiredExperience with Government
RequiredAnnual Turnover
RequiredOEM Authorization Certificate Bid to RA enabled No Patient Controlled Analgesic (PCA) Pump ( 6 pieces ) Technical Specifications * As per GeM Category Specification Specification Specification Name Values Bid Requirement (Allowed Values) Standards Conformity to Certifications EU - CE EU - CE
RequiredUS FDA
RequiredEU CE and US FDA Certification number and date - * Confirmity to Manufacturing Standards ISO 9001 & ISO 13485 ISO 9001 & ISO 13485
RequiredICMED 90001 & 13485
RequiredBoth ISO 9001 & ISO 1/7 13485 and ICMED 90001 & 13485 Conformity to Safety Standards IEC 60601-2-24 or BIS equivalent * Performance Parameters UMDNS Name and Code Infusion Pumps
RequiredAnalgesic
RequiredPatient- Controlled - 16-924 Infusion Pumps
RequiredAnalgesic
RequiredPatient- Controlled
RequiredAmbulatory - 28-080 * Purpose PCA infusion pumps are typically used to give pain relief to postoperative
Requiredobstetric
Requiredterminally ill
Requiredand trauma patients. They allow patients to self-administer boluses of narcotic analgesic intravenously
Requiredsubcutaneously
Requiredor epidurally
Requiredwhile keeping the amount within the prescribed limits. To avoid overmedication
Requiredan adjustable lockout interval inhibits delivery of additional boluses until the appropriate time (typically a few minutes to an hour) has elapsed. * Pump Capabilities PCA Pump Configuration type Ambulatory Ambulatory Flow range in mL/hr 0.01-1
Required500 0.01-1
Required500
Required0.1-2
Required000
Required0.1-50 Increments in mL/hr 0.1 0.1
Required0.01
Required0.05
Required1
Required10 Availability of bolus dose Yes * increments of bolus dose in mL/hr 0.05 0.1
Required0.05 Administration of initial bolus dose Yes Yes
RequiredNo Programming of dose concentrations Yes * KVO rate in mL/hr 2 1
Required2
Required3
Required4
Required5 Bar-code reader No Yes
RequiredNo 2/7 Safety Features Safety Parameters Lockbox
Requiredlocking keypad
Requiredmemory protection
Requiredtamper evident Lockbox
Requiredlocking keypad
Requiredmemory protection
Requiredtamper evident
RequiredLocking keypad
Requiredaccess code and/or electronic access key
Requiredmechanical lock with key for syringe
Requiredself-test (functional safety)
Required3 data lock levels with customizable codes
Requiredlockbox
Requiredsyringe holder cap
Requireddrug protocol library with dose limits
Required3 programmable lock levels
Requiredcassette detection
Requiredupstream occlusion
Requiredair-in-line detection
Requiredmedication cassettes
Requiredsecurity shell
Requiredfree-flow protection
RequiredSentry software for archiving and printing pump reports Free-flow protection Yes * Lockout interval range in minutes 5-100 * Controls access Key or security code * Patient control access Button type Cord type
RequiredButton type Reservoir Features Reservoir type IV Set Syringe
RequiredIV Set
RequiredCassette Volume capacity in mL ≥ 50 ≥ 50
Required≥ 100 Access to Reservoir Key
Requiredlockbox Key
Requiredlockbox
RequiredKey
Requiredaccess code Syringe Size Detection No No Alarms and Indicators Up/down occlusion Yes * Flow error Yes * Air in line Yes * System malfunction Yes * Empty reservoir Yes * Infusion near end Yes * Low battery Yes * Depleted battery Yes * 3/7 Online or battery power Yes Yes Cassette detached/attached Yes Yes
RequiredNo Syringe detached Attached Yes Yes
RequiredNo IV set Yes Yes
RequiredNo Soft limit overrides Yes Yes
RequiredNo Display changes when not using in protocol mode Yes Yes
RequiredNo Alarm for Volume control Yes Yes
RequiredNo Alarm for Momentary silence Yes * Others Features Dose Error Reduction System Yes Yes
RequiredNo Wireless connectivity Yes Yes
RequiredNo Auto documentation Yes Yes
RequiredNo Auto programming Yes Yes
RequiredNo Log-analysis software Yes Yes
RequiredNo Data Port USB RS232
RequiredUSB
RequiredWireless Event Log Printout No Yes
RequiredNo Time or date stamp Yes Yes
RequiredNo Number of events Yes Yes
RequiredNo Key presses event stored Yes * Error code event stored Yes Yes
RequiredNo Alarm event stored Yes Yes
RequiredNo Drug infused event stored Yes Yes
RequiredNo Drug amount infused stored Yes Yes
RequiredNo Setting event stroed Yes Yes
RequiredNo Boluses requested stored Yes Yes
RequiredNo System errors stored Yes Yes
RequiredNo Number of event stored 500 or more 500 or more Display Type of display LCD LCD
RequiredLED 4/7 Drug name displayed No Yes
RequiredNo Drug dose concentration displayed Yes Yes
RequiredNo Lockout interval displayed Yes Yes
RequiredNo Lockout rate displayed Yes Yes
RequiredNo Patient requests displayed Yes Yes
RequiredNo Alarms within or outside soft alarms Yes Yes
RequiredNo Battery life indicator Yes Yes
RequiredNo Infusion pressure Yes Yes
RequiredNo Infusion running volume Yes Yes
RequiredNo Time since infusion started No Yes
RequiredNo Remaining time to end infusion Yes Yes
RequiredNo Bolus demands Yes Yes
RequiredNo Bolus deliveries Yes Yes
RequiredNo Power Requirements Power Supply in VAC
RequiredHz 100-240 VAC
Required50-60 Hz * Battery type AA alkaline AA alkaline
RequiredLithium-ion Operating time of battery in hr ≥5 @ 10 mL/hr * Recharge time of battery in hr ≤6 ≤6
RequiredNA for Alkaline Miscellaneous Parameters User/Technical/Mainten ance manuals to be supplied in English in hard and soft copy Yes * Installation
RequiredDemonstration and training to be provided at consignee end Yes * The Principal Manufacturer Must Have Direct Presence/approved service center In India Yes * Warranty in Years 2 2 Copies of all certifications and reports to be provided to buyer on demand at Yes * 5/7 time of supplies QA
RequiredQC and other tests as per NABH shall be carried out by OEM or authorized agency of OEM Yes * * Specifications highlighted in bold are the Golden Parameters. * Bidders may note that In respect of non-golden Parameters
Requiredthe specifications 'Values' chosen by Buyer will generally be preferred over 'Bid requirement ( allowed Values) by the Buyer.
